54 Auditing Software jobs in the United States
Auditing & Compliance Director - Software as a Medical Device (SaMD)
Posted today
Job Viewed
Job Description
**OVERVIEW**
You will be the global product quality lead in support of a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important responsibilities include cross-functional correspondence, quality management reviews, audit support, change planning, and corrective and preventative action (CAPA)plans, with oversight of complaint trending, post-market surveillance, clinical evaluation, design control, and risk management activities. You will lead and participate in projects to enhance and maintain safety and performance of on-market products, interfacing with supplier and internal groups to drive product quality.
You will work with a core team of subject matter experts but must also work cross functionally within the business teams in Legal, Regulatory, Clinical, Marketing, and Product Development and within the broader Wolters Kluwer business to ensure consistent practices across the company.
You will report to the VP, Clinical Content Management
**RESPONSIBILITIES**
**Quality Management and Compliance**
+ Maintain and monitor Quality Management System (SOPs/WIs) in compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA, and EU MDR.
+ Perform design control activities focused on 21 CFR 820, ISO 13485, and IEC 62304.
+ Manage Risk Management Process in compliance with ISO 14971.
+ Identify gaps in existing processes and develop new processes.
+ Support external and internal audits; represent Quality Assurance as a subject matter expert.
+ Assure integration and support of device regulations and compliance with company policies and procedures.
**Supplier Management**
+ Perform supplier management activities, including review and approval of 3rd party design control activities, assess supplier changes, balance internal oversight actions and supplier controls, provide input to quality agreements, develop relationships, and visit supplier sites.
+ Support supplier audits as required.
**System Testing and Issue Resolution**
+ Manage and guide system testing activities, including verification and validation.
+ Lead resolution of quality issues with on-market device software; drive investigations related to product nonconformities and implement CAPA plans.
+ Serve as Quality approver for device software complaints and complaint trend evaluations.
+ Review and approve device software design control tasks or IT change requests in Service Now.
+ Support risk management/failure effect modes analysis (FMEA) activities for device software.
+ Drive change management process for device software launches and market expansions.
**Post-Market Surveillance and Regulatory Affairs**
+ Coordinate post-market activities including surveillance, trend reporting, adverse event reporting, and field safety corrective actions. Serve as Device QA approver for post-market surveillance and clinical evaluation plans/reports for SaMD products.
+ Monitor external regulatory trends to anticipate potential business/regulatory risks; communicate risks and lead implementation of regulatory measures.
+ Evaluate global regulatory landscape and advise cross-functional teams to ensure product compliance.
+ Prepare documentation and third-party testing for US and global registrations, license renewals, new product registrations, and product change registrations.
+ Ensure regulatory submissions are well-organized, scientifically accurate, high quality, and facilitate agency review.
+ Review design inputs and proposed design changes to ensure regulatory requirements are met.
+ Review product labeling and promotional materials for consistency with regulatory clearances.
+ Review new/revised regulations/standards; develop internal SOPs, WIs, and policies.
+ Continuously pursue regulatory knowledge to gain expertise in product submissions and regulatory topics.
+ Coach and mentor internal cross-functional teams on regulatory strategy and risk management.
**Collaboration and Strategy**
+ Foster global collaboration with cross-functional teams to identify and mitigate product risks.
+ Partner with internal business partners to solve technical and strategic challenges impacting the device portfolio.
+ Build and cultivate strong partnerships with internal business partners.
+ Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards.
**QUALIFICATIONS**
**Education:** Bachelor's Degree required. Clinical Degree preferred (e.g. PharmD / pharmacist, M.D. / medical doctor, etc.).
**Experience:**
+ 5+ years of quality and risk experience related to software as a medical device sold in the U.S., E.U., and globally.
+ Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP. Must have E.U. MDR and FDA Class II medical device experience, focused on software as a medical device.
**Other Knowledge, Skills, Abilities or Certifications:**
+ Working knowledge of ISO 13485, ISO 14971, IEC 62304, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)Thorough knowledge of ISO 13485 quality system requirements.
+ Experience compiling and submitting regulatory applications and submissions
+ Familiarity with SaMD is preferred.
+ Other compliance experience (i.e. EU RED, CPSC, FCC, RCM) preferred.
+ Be a detail-oriented with technical writing skills.
+ Ability to think critically and strategically, capable of effectively interpreting and communicating the impact of business initiatives, regulations, and industry trends to various stakeholders.
+ Possess interpersonal communication, teamwork, and organizational skills, able to build and leverage cross-functional relationships to gather insights and initiative continuous improvement.
+ Be a creative problem solver, adept at identifying root causes, evaluating optimal solutions, and recommending comprehensive upgrades to prevent future issues · Lead Auditor Certified, preferred · Regulatory Affairs Certification (RAC), preferred.
**TRAVEL:** Travel is minimal and tends to be irregular in frequency. The job will involve working with teams remotely on a regular basis. Travel requirements are variable and may include internal meetings, agency meetings, presentations and other travel.
#LI-Hybrid
_Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process._
**Compensation:**
Target salary range CA, CT, CO, DC, HI, IL, MD, MN, NY, RI, WA: $189,950 - $268,900
EQUAL EMPLOYMENT OPPORTUNITY Wolters Kluwer U. S. Corporation and all of its subsidiaries, divisions and customer/business units is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Auditing & Compliance Director - Software as a Medical Device (SaMD)
Posted 1 day ago
Job Viewed
Job Description
**OVERVIEW**
You will be the global product quality lead in support of a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important responsibilities include cross-functional correspondence, quality management reviews, audit support, change planning, and corrective and preventative action (CAPA)plans, with oversight of complaint trending, post-market surveillance, clinical evaluation, design control, and risk management activities. You will lead and participate in projects to enhance and maintain safety and performance of on-market products, interfacing with supplier and internal groups to drive product quality.
You will work with a core team of subject matter experts but must also work cross functionally within the business teams in Legal, Regulatory, Clinical, Marketing, and Product Development and within the broader Wolters Kluwer business to ensure consistent practices across the company.
You will report to the VP, Clinical Content Management
**RESPONSIBILITIES**
**Quality Management and Compliance**
+ Maintain and monitor Quality Management System (SOPs/WIs) in compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA, and EU MDR.
+ Perform design control activities focused on 21 CFR 820, ISO 13485, and IEC 62304.
+ Manage Risk Management Process in compliance with ISO 14971.
+ Identify gaps in existing processes and develop new processes.
+ Support external and internal audits; represent Quality Assurance as a subject matter expert.
+ Assure integration and support of device regulations and compliance with company policies and procedures.
**Supplier Management**
+ Perform supplier management activities, including review and approval of 3rd party design control activities, assess supplier changes, balance internal oversight actions and supplier controls, provide input to quality agreements, develop relationships, and visit supplier sites.
+ Support supplier audits as required.
**System Testing and Issue Resolution**
+ Manage and guide system testing activities, including verification and validation.
+ Lead resolution of quality issues with on-market device software; drive investigations related to product nonconformities and implement CAPA plans.
+ Serve as Quality approver for device software complaints and complaint trend evaluations.
+ Review and approve device software design control tasks or IT change requests in Service Now.
+ Support risk management/failure effect modes analysis (FMEA) activities for device software.
+ Drive change management process for device software launches and market expansions.
**Post-Market Surveillance and Regulatory Affairs**
+ Coordinate post-market activities including surveillance, trend reporting, adverse event reporting, and field safety corrective actions. Serve as Device QA approver for post-market surveillance and clinical evaluation plans/reports for SaMD products.
+ Monitor external regulatory trends to anticipate potential business/regulatory risks; communicate risks and lead implementation of regulatory measures.
+ Evaluate global regulatory landscape and advise cross-functional teams to ensure product compliance.
+ Prepare documentation and third-party testing for US and global registrations, license renewals, new product registrations, and product change registrations.
+ Ensure regulatory submissions are well-organized, scientifically accurate, high quality, and facilitate agency review.
+ Review design inputs and proposed design changes to ensure regulatory requirements are met.
+ Review product labeling and promotional materials for consistency with regulatory clearances.
+ Review new/revised regulations/standards; develop internal SOPs, WIs, and policies.
+ Continuously pursue regulatory knowledge to gain expertise in product submissions and regulatory topics.
+ Coach and mentor internal cross-functional teams on regulatory strategy and risk management.
**Collaboration and Strategy**
+ Foster global collaboration with cross-functional teams to identify and mitigate product risks.
+ Partner with internal business partners to solve technical and strategic challenges impacting the device portfolio.
+ Build and cultivate strong partnerships with internal business partners.
+ Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards.
**QUALIFICATIONS**
**Education:** Bachelor's Degree required. Clinical Degree preferred (e.g. PharmD / pharmacist, M.D. / medical doctor, etc.).
**Experience:**
+ 5+ years of quality and risk experience related to software as a medical device sold in the U.S., E.U., and globally.
+ Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP. Must have E.U. MDR and FDA Class II medical device experience, focused on software as a medical device.
**Other Knowledge, Skills, Abilities or Certifications:**
+ Working knowledge of ISO 13485, ISO 14971, IEC 62304, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)Thorough knowledge of ISO 13485 quality system requirements.
+ Experience compiling and submitting regulatory applications and submissions
+ Familiarity with SaMD is preferred.
+ Other compliance experience (i.e. EU RED, CPSC, FCC, RCM) preferred.
+ Be a detail-oriented with technical writing skills.
+ Ability to think critically and strategically, capable of effectively interpreting and communicating the impact of business initiatives, regulations, and industry trends to various stakeholders.
+ Possess interpersonal communication, teamwork, and organizational skills, able to build and leverage cross-functional relationships to gather insights and initiative continuous improvement.
+ Be a creative problem solver, adept at identifying root causes, evaluating optimal solutions, and recommending comprehensive upgrades to prevent future issues · Lead Auditor Certified, preferred · Regulatory Affairs Certification (RAC), preferred.
**TRAVEL:** Travel is minimal and tends to be irregular in frequency. The job will involve working with teams remotely on a regular basis. Travel requirements are variable and may include internal meetings, agency meetings, presentations and other travel.
#LI-Hybrid
_Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process._
**Compensation:**
Target salary range CA, CT, CO, DC, HI, IL, MD, MN, NY, RI, WA: $189,950 - $268,900
EQUAL EMPLOYMENT OPPORTUNITY Wolters Kluwer U. S. Corporation and all of its subsidiaries, divisions and customer/business units is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Auditing & Compliance Director - Software as a Medical Device (SaMD)
Posted 1 day ago
Job Viewed
Job Description
**OVERVIEW**
You will be the global product quality lead in support of a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important responsibilities include cross-functional correspondence, quality management reviews, audit support, change planning, and corrective and preventative action (CAPA)plans, with oversight of complaint trending, post-market surveillance, clinical evaluation, design control, and risk management activities. You will lead and participate in projects to enhance and maintain safety and performance of on-market products, interfacing with supplier and internal groups to drive product quality.
You will work with a core team of subject matter experts but must also work cross functionally within the business teams in Legal, Regulatory, Clinical, Marketing, and Product Development and within the broader Wolters Kluwer business to ensure consistent practices across the company.
You will report to the VP, Clinical Content Management
**RESPONSIBILITIES**
**Quality Management and Compliance**
+ Maintain and monitor Quality Management System (SOPs/WIs) in compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA, and EU MDR.
+ Perform design control activities focused on 21 CFR 820, ISO 13485, and IEC 62304.
+ Manage Risk Management Process in compliance with ISO 14971.
+ Identify gaps in existing processes and develop new processes.
+ Support external and internal audits; represent Quality Assurance as a subject matter expert.
+ Assure integration and support of device regulations and compliance with company policies and procedures.
**Supplier Management**
+ Perform supplier management activities, including review and approval of 3rd party design control activities, assess supplier changes, balance internal oversight actions and supplier controls, provide input to quality agreements, develop relationships, and visit supplier sites.
+ Support supplier audits as required.
**System Testing and Issue Resolution**
+ Manage and guide system testing activities, including verification and validation.
+ Lead resolution of quality issues with on-market device software; drive investigations related to product nonconformities and implement CAPA plans.
+ Serve as Quality approver for device software complaints and complaint trend evaluations.
+ Review and approve device software design control tasks or IT change requests in Service Now.
+ Support risk management/failure effect modes analysis (FMEA) activities for device software.
+ Drive change management process for device software launches and market expansions.
**Post-Market Surveillance and Regulatory Affairs**
+ Coordinate post-market activities including surveillance, trend reporting, adverse event reporting, and field safety corrective actions. Serve as Device QA approver for post-market surveillance and clinical evaluation plans/reports for SaMD products.
+ Monitor external regulatory trends to anticipate potential business/regulatory risks; communicate risks and lead implementation of regulatory measures.
+ Evaluate global regulatory landscape and advise cross-functional teams to ensure product compliance.
+ Prepare documentation and third-party testing for US and global registrations, license renewals, new product registrations, and product change registrations.
+ Ensure regulatory submissions are well-organized, scientifically accurate, high quality, and facilitate agency review.
+ Review design inputs and proposed design changes to ensure regulatory requirements are met.
+ Review product labeling and promotional materials for consistency with regulatory clearances.
+ Review new/revised regulations/standards; develop internal SOPs, WIs, and policies.
+ Continuously pursue regulatory knowledge to gain expertise in product submissions and regulatory topics.
+ Coach and mentor internal cross-functional teams on regulatory strategy and risk management.
**Collaboration and Strategy**
+ Foster global collaboration with cross-functional teams to identify and mitigate product risks.
+ Partner with internal business partners to solve technical and strategic challenges impacting the device portfolio.
+ Build and cultivate strong partnerships with internal business partners.
+ Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards.
**QUALIFICATIONS**
**Education:** Bachelor's Degree required. Clinical Degree preferred (e.g. PharmD / pharmacist, M.D. / medical doctor, etc.).
**Experience:**
+ 5+ years of quality and risk experience related to software as a medical device sold in the U.S., E.U., and globally.
+ Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP. Must have E.U. MDR and FDA Class II medical device experience, focused on software as a medical device.
**Other Knowledge, Skills, Abilities or Certifications:**
+ Working knowledge of ISO 13485, ISO 14971, IEC 62304, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)Thorough knowledge of ISO 13485 quality system requirements.
+ Experience compiling and submitting regulatory applications and submissions
+ Familiarity with SaMD is preferred.
+ Other compliance experience (i.e. EU RED, CPSC, FCC, RCM) preferred.
+ Be a detail-oriented with technical writing skills.
+ Ability to think critically and strategically, capable of effectively interpreting and communicating the impact of business initiatives, regulations, and industry trends to various stakeholders.
+ Possess interpersonal communication, teamwork, and organizational skills, able to build and leverage cross-functional relationships to gather insights and initiative continuous improvement.
+ Be a creative problem solver, adept at identifying root causes, evaluating optimal solutions, and recommending comprehensive upgrades to prevent future issues · Lead Auditor Certified, preferred · Regulatory Affairs Certification (RAC), preferred.
**TRAVEL:** Travel is minimal and tends to be irregular in frequency. The job will involve working with teams remotely on a regular basis. Travel requirements are variable and may include internal meetings, agency meetings, presentations and other travel.
#LI-Hybrid
_Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process._
**Compensation:**
Target salary range CA, CT, CO, DC, HI, IL, MD, MN, NY, RI, WA: $189,950 - $268,900
EQUAL EMPLOYMENT OPPORTUNITY Wolters Kluwer U. S. Corporation and all of its subsidiaries, divisions and customer/business units is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Auditing & Compliance Director - Software as a Medical Device (SaMD)
Posted 5 days ago
Job Viewed
Job Description
**OVERVIEW**
You will be the global product quality lead in support of a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important responsibilities include cross-functional correspondence, quality management reviews, audit support, change planning, and corrective and preventative action (CAPA)plans, with oversight of complaint trending, post-market surveillance, clinical evaluation, design control, and risk management activities. You will lead and participate in projects to enhance and maintain safety and performance of on-market products, interfacing with supplier and internal groups to drive product quality.
You will work with a core team of subject matter experts but must also work cross functionally within the business teams in Legal, Regulatory, Clinical, Marketing, and Product Development and within the broader Wolters Kluwer business to ensure consistent practices across the company.
You will report to the VP, Clinical Content Management
**RESPONSIBILITIES**
**Quality Management and Compliance**
+ Maintain and monitor Quality Management System (SOPs/WIs) in compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA, and EU MDR.
+ Perform design control activities focused on 21 CFR 820, ISO 13485, and IEC 62304.
+ Manage Risk Management Process in compliance with ISO 14971.
+ Identify gaps in existing processes and develop new processes.
+ Support external and internal audits; represent Quality Assurance as a subject matter expert.
+ Assure integration and support of device regulations and compliance with company policies and procedures.
**Supplier Management**
+ Perform supplier management activities, including review and approval of 3rd party design control activities, assess supplier changes, balance internal oversight actions and supplier controls, provide input to quality agreements, develop relationships, and visit supplier sites.
+ Support supplier audits as required.
**System Testing and Issue Resolution**
+ Manage and guide system testing activities, including verification and validation.
+ Lead resolution of quality issues with on-market device software; drive investigations related to product nonconformities and implement CAPA plans.
+ Serve as Quality approver for device software complaints and complaint trend evaluations.
+ Review and approve device software design control tasks or IT change requests in Service Now.
+ Support risk management/failure effect modes analysis (FMEA) activities for device software.
+ Drive change management process for device software launches and market expansions.
**Post-Market Surveillance and Regulatory Affairs**
+ Coordinate post-market activities including surveillance, trend reporting, adverse event reporting, and field safety corrective actions. Serve as Device QA approver for post-market surveillance and clinical evaluation plans/reports for SaMD products.
+ Monitor external regulatory trends to anticipate potential business/regulatory risks; communicate risks and lead implementation of regulatory measures.
+ Evaluate global regulatory landscape and advise cross-functional teams to ensure product compliance.
+ Prepare documentation and third-party testing for US and global registrations, license renewals, new product registrations, and product change registrations.
+ Ensure regulatory submissions are well-organized, scientifically accurate, high quality, and facilitate agency review.
+ Review design inputs and proposed design changes to ensure regulatory requirements are met.
+ Review product labeling and promotional materials for consistency with regulatory clearances.
+ Review new/revised regulations/standards; develop internal SOPs, WIs, and policies.
+ Continuously pursue regulatory knowledge to gain expertise in product submissions and regulatory topics.
+ Coach and mentor internal cross-functional teams on regulatory strategy and risk management.
**Collaboration and Strategy**
+ Foster global collaboration with cross-functional teams to identify and mitigate product risks.
+ Partner with internal business partners to solve technical and strategic challenges impacting the device portfolio.
+ Build and cultivate strong partnerships with internal business partners.
+ Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards.
**QUALIFICATIONS**
**Education:** Bachelor's Degree required. Clinical Degree preferred (e.g. PharmD / pharmacist, M.D. / medical doctor, etc.).
**Experience:**
+ 5+ years of quality and risk experience related to software as a medical device sold in the U.S., E.U., and globally.
+ Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP. Must have E.U. MDR and FDA Class II medical device experience, focused on software as a medical device.
**Other Knowledge, Skills, Abilities or Certifications:**
+ Working knowledge of ISO 13485, ISO 14971, IEC 62304, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)Thorough knowledge of ISO 13485 quality system requirements.
+ Experience compiling and submitting regulatory applications and submissions
+ Familiarity with SaMD is preferred.
+ Other compliance experience (i.e. EU RED, CPSC, FCC, RCM) preferred.
+ Be a detail-oriented with technical writing skills.
+ Ability to think critically and strategically, capable of effectively interpreting and communicating the impact of business initiatives, regulations, and industry trends to various stakeholders.
+ Possess interpersonal communication, teamwork, and organizational skills, able to build and leverage cross-functional relationships to gather insights and initiative continuous improvement.
+ Be a creative problem solver, adept at identifying root causes, evaluating optimal solutions, and recommending comprehensive upgrades to prevent future issues · Lead Auditor Certified, preferred · Regulatory Affairs Certification (RAC), preferred.
**TRAVEL:** Travel is minimal and tends to be irregular in frequency. The job will involve working with teams remotely on a regular basis. Travel requirements are variable and may include internal meetings, agency meetings, presentations and other travel.
#LI-Hybrid
_Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process._
**Compensation:**
Target salary range CA, CT, CO, DC, HI, IL, MD, MN, NY, RI, WA: $189,950 - $268,900
EQUAL EMPLOYMENT OPPORTUNITY Wolters Kluwer U. S. Corporation and all of its subsidiaries, divisions and customer/business units is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Auditing & Compliance Director - Software as a Medical Device (SaMD)
Posted 11 days ago
Job Viewed
Job Description
**OVERVIEW**
You will be the global product quality lead in support of a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important responsibilities include cross-functional correspondence, quality management reviews, audit support, change planning, and corrective and preventative action (CAPA)plans, with oversight of complaint trending, post-market surveillance, clinical evaluation, design control, and risk management activities. You will lead and participate in projects to enhance and maintain safety and performance of on-market products, interfacing with supplier and internal groups to drive product quality.
You will work with a core team of subject matter experts but must also work cross functionally within the business teams in Legal, Regulatory, Clinical, Marketing, and Product Development and within the broader Wolters Kluwer business to ensure consistent practices across the company.
You will report to the VP, Clinical Content Management
**RESPONSIBILITIES**
**Quality Management and Compliance**
+ Maintain and monitor Quality Management System (SOPs/WIs) in compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA, and EU MDR.
+ Perform design control activities focused on 21 CFR 820, ISO 13485, and IEC 62304.
+ Manage Risk Management Process in compliance with ISO 14971.
+ Identify gaps in existing processes and develop new processes.
+ Support external and internal audits; represent Quality Assurance as a subject matter expert.
+ Assure integration and support of device regulations and compliance with company policies and procedures.
**Supplier Management**
+ Perform supplier management activities, including review and approval of 3rd party design control activities, assess supplier changes, balance internal oversight actions and supplier controls, provide input to quality agreements, develop relationships, and visit supplier sites.
+ Support supplier audits as required.
**System Testing and Issue Resolution**
+ Manage and guide system testing activities, including verification and validation.
+ Lead resolution of quality issues with on-market device software; drive investigations related to product nonconformities and implement CAPA plans.
+ Serve as Quality approver for device software complaints and complaint trend evaluations.
+ Review and approve device software design control tasks or IT change requests in Service Now.
+ Support risk management/failure effect modes analysis (FMEA) activities for device software.
+ Drive change management process for device software launches and market expansions.
**Post-Market Surveillance and Regulatory Affairs**
+ Coordinate post-market activities including surveillance, trend reporting, adverse event reporting, and field safety corrective actions. Serve as Device QA approver for post-market surveillance and clinical evaluation plans/reports for SaMD products.
+ Monitor external regulatory trends to anticipate potential business/regulatory risks; communicate risks and lead implementation of regulatory measures.
+ Evaluate global regulatory landscape and advise cross-functional teams to ensure product compliance.
+ Prepare documentation and third-party testing for US and global registrations, license renewals, new product registrations, and product change registrations.
+ Ensure regulatory submissions are well-organized, scientifically accurate, high quality, and facilitate agency review.
+ Review design inputs and proposed design changes to ensure regulatory requirements are met.
+ Review product labeling and promotional materials for consistency with regulatory clearances.
+ Review new/revised regulations/standards; develop internal SOPs, WIs, and policies.
+ Continuously pursue regulatory knowledge to gain expertise in product submissions and regulatory topics.
+ Coach and mentor internal cross-functional teams on regulatory strategy and risk management.
**Collaboration and Strategy**
+ Foster global collaboration with cross-functional teams to identify and mitigate product risks.
+ Partner with internal business partners to solve technical and strategic challenges impacting the device portfolio.
+ Build and cultivate strong partnerships with internal business partners.
+ Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards.
**QUALIFICATIONS**
**Education:** Bachelor's Degree required. Clinical Degree preferred (e.g. PharmD / pharmacist, M.D. / medical doctor, etc.).
**Experience:**
+ 5+ years of quality and risk experience related to software as a medical device sold in the U.S., E.U., and globally.
+ Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP. Must have E.U. MDR and FDA Class II medical device experience, focused on software as a medical device.
**Other Knowledge, Skills, Abilities or Certifications:**
+ Working knowledge of ISO 13485, ISO 14971, IEC 62304, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)Thorough knowledge of ISO 13485 quality system requirements.
+ Experience compiling and submitting regulatory applications and submissions
+ Familiarity with SaMD is preferred.
+ Other compliance experience (i.e. EU RED, CPSC, FCC, RCM) preferred.
+ Be a detail-oriented with technical writing skills.
+ Ability to think critically and strategically, capable of effectively interpreting and communicating the impact of business initiatives, regulations, and industry trends to various stakeholders.
+ Possess interpersonal communication, teamwork, and organizational skills, able to build and leverage cross-functional relationships to gather insights and initiative continuous improvement.
+ Be a creative problem solver, adept at identifying root causes, evaluating optimal solutions, and recommending comprehensive upgrades to prevent future issues · Lead Auditor Certified, preferred · Regulatory Affairs Certification (RAC), preferred.
**TRAVEL:** Travel is minimal and tends to be irregular in frequency. The job will involve working with teams remotely on a regular basis. Travel requirements are variable and may include internal meetings, agency meetings, presentations and other travel.
#LI-Hybrid
_Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process._
**Compensation:**
Target salary range CA, CT, CO, DC, HI, IL, MD, MN, NY, RI, WA: $189,950 - $268,900
EQUAL EMPLOYMENT OPPORTUNITY Wolters Kluwer U. S. Corporation and all of its subsidiaries, divisions and customer/business units is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Senior Compliance Software Engineer (Product)
Posted today
Job Viewed
Job Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Senior Compliance Software Engineer (Product) Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity The Sr. Compliance Software Engineer (Product) will be responsible (but not limited to) the following: Participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software. Coordinate activities with other engineering disciplines, departments, and contractors. What You'll Work On Completes software quality tasks in accordance with current Quality System Requirements. Works independently with objectives given by SWQA Manager. Can plan and coordinate own work according to higher-level project schedules. Reviews and provides lead guidance to the team regarding deliverables/activities as identified in project plans or equivalent documentation. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site. Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management. Assists subordinate staff in recognizing the same. Coordinates the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA, QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of application in support of medical device software. Software Quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies software development activities. Maintains schedule and drive to meet project schedule as aligned with project(s) goals. Will also estimate, plan, schedule and review own and others’ work products and be accountable for the quality of those reviews and delivery on schedule. Considered Non-Product SWQA compliance SME in support of external/internal audits. Required Qualifications Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline. 5 to 8 years’ experience in Software Quality Assurance and/or Software Testing experience. Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements. Must have 2 - 4 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices. Must have excellent oral and written communication skills. Preferred Qualifications: ASQ Certifications a plus. Experience in working in a regulated environment strongly preferred. Cybersecurity, familiarity in AI, and cloud computing experience preferred. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at , and on Twitter @AbbottNews. Divisional Information Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Diabetes We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The base pay for this position is $98,000.00 – $196,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ADC Diabetes Care LOCATION: United States > Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: is the Law link - Espanol: #J-18808-Ljbffr
Senior Compliance Software Engineer (Product)
Posted 2 days ago
Job Viewed
Job Description
Senior Compliance Software Engineer (Product) Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity The Sr. Compliance Software Engineer (Product) will be responsible (but not limited to) the following: Participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software. Coordinate activities with other engineering disciplines, departments, and contractors. What You'll Work On Completes software quality tasks in accordance with current Quality System Requirements. Works independently with objectives given by SWQA Manager. Can plan and coordinate own work according to higher-level project schedules. Reviews and provides lead guidance to the team regarding deliverables/activities as identified in project plans or equivalent documentation. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site. Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management. Assists subordinate staff in recognizing the same. Coordinates the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA, QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of application in support of medical device software. Software Quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies software development activities. Maintains schedule and drive to meet project schedule as aligned with project(s) goals. Will also estimate, plan, schedule and review own and others’ work products and be accountable for the quality of those reviews and delivery on schedule. Considered Non-Product SWQA compliance SME in support of external/internal audits. Required Qualifications Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline. 5 to 8 years’ experience in Software Quality Assurance and/or Software Testing experience. Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements. Must have 2 - 4 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices. Must have excellent oral and written communication skills. Preferred Qualifications: ASQ Certifications a plus. Experience in working in a regulated environment strongly preferred. Cybersecurity, familiarity in AI, and cloud computing experience preferred. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at , and on Twitter @AbbottNews. Divisional Information Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Diabetes We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The base pay for this position is $98,000.00 – $196,000.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr
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Senior Compliance Software Engineer (Product)
Posted 1 day ago
Job Viewed
Job Description
**Senior Compliance Software Engineer (Product)**
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
+ An excellent retirement savings plan with high employer contribution
+ Tuition reimbursement, the Freedom 2 Save ( student debt program and FreeU ( education benefit - an affordable and convenient path to getting a bachelor's degree.
+ A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
The Sr. Compliance Software Engineer (Product) will be responsible (but not limited to) the following:
+ Participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements.
+ Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software.
+ Coordinate activities with other engineering disciplines, departments, and contractors.
**What You'll Work On**
+ Completes software quality tasks in accordance with current Quality System Requirements.
+ Works independently with objectives given by SWQA Manager.
+ Can plan and coordinate own work according to higher-level project schedules.
+ Reviews and provides lead guidance to the team regarding deliverables/activities as identified in project plans or equivalent documentation. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site.
+ Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management. Assists subordinate staff in recognizing the same.
+ Coordinates the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA, QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of application in support of medical device software.
+ Software Quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies software development activities.
+ Maintains schedule and drive to meet project schedule as aligned with project(s) goals.
+ Will also estimate, plan, schedule and review own and others' work products and be accountable for the quality of those reviews and delivery on schedule.
+ Considered Non-Product SWQA compliance SME in support of external/internal audits.
**Required Qualifications**
+ Bachelor's degree, or equivalent experience, in a scientific, technical, or engineering discipline.
+ 5 to 8 years' experience in Software Quality Assurance and/or Software Testing experience.
+ Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.
+ Must have 2 - 4 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices.
+ Must have excellent oral and written communication skills.
**Preferred Qualifications:**
+ ASQ Certifications a plus.
+ Experience in working in a regulated environment strongly preferred.
+ Cybersecurity, familiarity in AI, and cloud computing experience preferred.
Apply Now ( more about our health and wellness benefits, which provide the security to help you and your family live full lives:** ( your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at , and on Twitter @AbbottNews.
**Divisional Information**
Medical Devices
General Medical Devices:
Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks.
Diabetes
We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
The base pay for this position is $98,000.00 - $196,000.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Forvis Mazars, Associate Audit October 2026 - Application via WayUp (Atlanta)
Posted 5 days ago
Job Viewed
Job Description
Description & Requirements
Are you an accounting student striving for CPA eligibility and looking for a full-time opportunity in Audit? At FORVIS, you can use your critical thinking abilities to help clients solve problems or apply your social skills to build rewarding business relationships. You will work with clients from a variety of industries as you develop your technical skills and strengthen the foundation on which you will build your career.
Whether you choose to start in audit or tax, you will be coached by our experienced staff and management personnel. As your skill set grows, you will assume greater responsibility and actively participate in determining your career path.
How you will contribute:
- Completing audit testing on financial statement accounts such as cash, accounts payable, or fixed assets
- Working with client personnel to reconcile account differences and analyze financial data
- Helping to draft management letter comments and the audit report
- Participating in client meetings alongside FORVIS partners and managers
We are looking for people who have Forward Vision and:
- Effective time management
- Strong oral and written communication skills
- Ability to work well with a team as well as independently
- Problem-solving attitude
- Willingness to take initiative
- Close attention to detail
- Ability to work under pressure and against deadlines
Minimum Qualifications:
- Associate positions require a bachelor's or master's degree in accounting
- Associates must be eligible to sit for the CPA exam in the state in which your office will be located
- Solid technical accounting knowledge
- Proficiency in Microsoft Office Suite
Preferred Qualifications:
- Prior internships in a public accounting firm performing audit work
Applicants for positions with FORVIS must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available for this position.
At FORVIS, your career is designed with a purpose. We want our team members to thrive professionally and feel the impact their work yields when serving clients, industries, and local communities. This starts by empowering team members to design a career journey that leverages their skills and fuels their passions.
Creating a best-in-class employee experience is at the heart of our vision for the future. With a global presence and diversified service offerings, we provide our FORVIS team members with an abundance of career paths to choose from. We pride ourselves on building an inclusive culture where the backgrounds and talents of all our people are valued. We view our people as our most important asset and invest in them by providing competitive total rewards, professional development, and rewarding career opportunities.
About FORVIS
FORVIS, LLP ranks among the nation’s top 10 professional services firms. Created by the merger of equals of BKD, LLP and Dixon Hughes Goodman, LLP (DHG), FORVIS is driven by the commitment to use our forward vision to deliver Unmatched Client Experiences. FORVIS is built upon the strong legacies of BKD and DHG, which is reflected in a name that comprises partner initials and represents our unique focus on preparing our clients for what is next. With more than 5,500 dedicated professionals who serve clients in all 50 states as well as across the globe, FORVIS offers assurance, tax, advisory, and wealth management services.
Design your career with purpose at FORVIS. For more information about our firm locations, visit FORVIS.com. FORVIS, LLP is an equal opportunity/affirmative action employer. Employment selection and related decisions are made without regard to age, race, color, sex, sexual orientation, national origin, religion, genetic information, disability, protected veteran status, or other protected classifications.
It is FORVIS's standard policy not to accept unsolicited referrals or resumes from any source other than directly from candidates.
- FORVIS expressly reserves the right not to consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services, and recruiting agencies.
- FORVIS further reserves the right not to pay a fee to a recruiter or agency unless such recruiter or agency has a signed vendor agreement with FORVIS.
- Any resume or CV submitted to any employee of FORVIS without having a FORVIS vendor agreement in place will be considered the property of FORVIS.
Software Compliance Engineer
Posted 5 days ago
Job Viewed
Job Description
- Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensure that business needs are met
- Application of ISO 13485, QSR 820, and ISO 14971 standards, especially 21 CFR 30 design controls to software development projects.
- Implementation of 21 CFR Part 11 Compliance, Data Privacy Software controls
- Participate in the completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments
- Perform labeling verification and generate labeling verification reports
- Complete Document Change Request Reviews in a timely and objective manner
- Work with design engineering in the completion of software/system requirements
- Work with design engineering in the completion of product verification and validation
- Participate in the development process to support quality disciplines, decisions, and practices
- Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
- Identify and implement effective process control systems to support the development, qualification, and on- going manufacturing of products to meet or exceed internal and external requirements
- Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
- Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
- Supports business during regulatory and supplier audits
- Complies with S. Food and Drug Administration (FDA) regulations, Health Canada regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Performs other related duties and responsibilities, on occasion, as assigned
Knowledge, Skills and Abilities:
- Excellent written and verbal communication and interpersonal skills
- Knowledge of medical device design controls requirements from FDA, ISO and other global regulatory
- Knowledge on AAMIISO TIR80002-22017 and TIR362007
- Advanced computer skills, including statistical/data analysis and report writing skills
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Extensive experience and knowledge of computer hardware, computer networking, Microsoft operating systems and Microsoft Office Suite (Word, Excel and Outlook)
- Self-motivated and to effectively manage multiple projects
- Ability to follow DI's policy and procedures
- Proven problem-solving approach
- Process Improvement Mindset
- Must comply with and pass initial background check and drug screening, as well as subsequent background checks, drug screenings and vaccine requirements as required by customer contracts
- Must comply with company vaccination policy
Bachelor's degree in Computer Science/Engineering or 1-2 years' Software Quality Engineering experience OR 4 years' experience working in a related field from which comparable knowledge and skills can be acquired.
Preferred Skills or Experience
In addition to the above requirements, the ideal employee/candidate will have experience with the following:
- Experience with iOS and mobile apps development
- Experience with products developed using Agile software development practices
- Experience with medical device software in the cloud and software as a service (SaaS)
- Clinical laboratory space and workflow knowledge
- Healthcare IT Software
- Previous experience with Instrument Manager
- Project Management
- Certified or ability to certify as ASQ Software Quality Engineer (ASQ CSQE)
Physical Requirements/Working Conditions:
While performing duties of this job, the employee is predominately functioning in a sedentary light office position with high frequency of telephone communication, keyboarding, and computer.
Supervision Level
This person reports directly to the Director of Quality Regulatory and may mentor others in the department.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.