9,569 Quality Management System jobs in the United States
Quality Management System Administrator
Posted today
Job Viewed
Job Description
Job Location
Ann Arbor MI - Ann Arbor, MI
Position Type
Full Time
Education Level
2 Year Degree
Salary Range
$33.25 - $36.25 Hourly
Travel Percentage
Negligible
Job Shift
Day
Job Category
QA - Quality Control
Description
Summary
In alignment with Gift of Life Michigan's core purpose and core values, the Quality Management System Administrator is responsible for administering and maintaining Gift of Life's electronic Quality Management System (QMS, currently Q-Pulse). This includes managing various modules and workflows, conducting system maintenance, and managing document reviews, which includes facilitating document training. Additionally, this position requires maintaining QMS resources and facilitating staff training.
Duties & Responsibilities
The following job duties and responsibilities are stated in broad terms and not intended to be inclusive. Those in bold are essential duties of the position:
- Assume direct responsibility for managing, administering, and maintaining the QMS to ensure compliance with federal, state, accreditation and other third party legal and regulatory requirements and standards.
- Serve as the subject matter expert of the electronic QMS. Responsible for all administration and maintenance functions related to all Modules used by Gift of Life (i.e., Assets, Audits, Documents, People, Supplier, Training, Incident, Reporting Forms and Administration Modules).
- Create, edit and/or compile reports, records, checklists, managed lists, templates, and workflows.
- Create, edit, develop and/or compile various QMS reports for data analytics, tracking and trending.
- Manage user accounts, preferences, and security groups. Responsible for creating new users, disabling users, credentialing, and configuration management.
- Maintain and manage document records and approval templates. Support document workflows (i.e., creation, revision and archival) of controlled documents.
- Administer document trainings, complete training records, and facilitate training with end-users and new hires.
- Manage the annual review of controlled documents and collaborate with internal departments on proposed revisions to ensure compliance to regulatory requirements.
- Develop QMS reference documents, materials and job aids, etc. related to electronic quality management system functions to support end user needs. Additionally, develop various QMS reports for data analytics, tracking and trending.
- Support quality assurance and improvement initiatives, utilizing critical thinking skills to drive continuous improvement.
- Continuously evaluate electronic QMS platforms and or perform QSP functions to promote the evolution of the current electronic QMS.
- Perform other duties as assigned.
Qualifications
Education and/or Experience
Required
- Associate degree in business, information technology, health sciences or a related field, and/or combination or education and experience.
- One year of quality or relevant document control experience.
- Experience with QMS such as, Q-Pulse software, or electronic systems administration.
- Prior experience successfully leading a project team, workgroup, etc.
- Experience fostering relationships and providing exemplary customer service to internal customers.
- Prior experience in a healthcare organization, transplant center, or organ/tissue procurement organization.
- Written and verbal fluency in English.
- Ability to exercise initiative, critical thinking, and problem-solving.
- Proficiency with Microsoft Office programs, including Outlook and Teams and other technology systems used in business operations.
- Strong organizational skills and ability to manage multiple and competing priorities.
- Demonstrate attention to detail.
- Knowledge of quality, quality improvement methodologies and the ability to apply appropriate quality tools and techniques.
- Strong presentation skills to audiences of varying backgrounds and sizes.
- Excellent verbal and written communication.
- Demonstrate the competencies of Professional, Determined and Compassionate.
- Maintain a motivated and positive attitude.
- Support an inclusive work environment.
- Ability to successfully collaborate and work as a member of an interdisciplinary team.
- Actively seek improvements.
- Always maintain a safe working environment and use of Universal Precautions.
- Maintain appropriate level of confidentiality in all areas dealing with sensitive, protected, and confidential information.
QUALITY MANAGEMENT SYSTEM SPECIALIST
Posted today
Job Viewed
Job Description
Job Type
Full-time
Description
Building Automation Products, Inc (BAPI) is a company that promotes work life balance. BAPI is a family owned business with a global presence.
Position Summary: The Quality Management System (QMS) Specialist adds value to BAPI and by supporting the development, implementation, maintenance, and continuous improvement of the organization's Quality Management System in compliance with ISO 9001:2015 and other applicable quality standards. This role plays a key part in document control, internal audits, corrective actions, training support, and QMS data analysis, helping drive a culture of quality and continuous improvement.
Benefits: Relocation reimbursement, full benefits which include Health, dental, vision, PTO, 8 paid holidays, 401k match and 100% vested at 90 days and more.
Quality Management System (QMS) Specialist Principle Responsibilities:
QMS System Maintenance and Audits
* Maintain and update QMS documentation, including procedures, work instructions, forms, and records in compliance with ISO 9001:2015 and company requirements.
* Support and participate in internal audit activities, including planning, execution, reporting, and follow-up.
* Assist with external audits by certification bodies, customers, and regulatory agencies.
Continuous Improvement
* Monitor and track nonconformities, corrective and preventive actions (CAPAs), and ensure timely closure with proper documentation and effectiveness reviews.
* Support continuous improvement initiatives through data collection, analysis, and process improvement tracking.
* Maintain document control systems and ensure proper version control and access.
* Ensure compliance with customer and regulatory requirements relating to quality documentation and recordkeeping.
Training and Development
* Provide administrative support for quality initiatives such as management review meetings, risk assessments, and KPI tracking.
* Train or assist in training employees on QMS procedures, document access, and quality awareness
* Collaborate with cross-functional teams to promote best practices and ensure process alignment with QMS standards.
Achieve Metrics:
* QMS documentation maintained accurately and in compliance.
* Timely execution and follow-up of internal audits and CAPAs.
* Positive audit outcomes (internal and external).
* Training completion rates and employee awareness of QMS procedures.
* Responsiveness and support for quality initiatives.
Maintains industry knowledge by attending educational workshops or classes; reviewing related publications; establishing networks.
Contributes to team effort by accomplishing related results as needed, including special projects and tasks as delegated supervisor.
Requirements
Quality Management System (QMS) Specialist Education Requirements (R/Required, P/Preferred):
(P) Bachelor's degree
Degrees Preferred: Engineering, Business, or related technical
Training, Skills, Knowledge and Experience
Specific Training in this field (R/Required, P/Preferred):
* (R) Internal Auditor Certification for ISO 9001 (or willingness to obtain).
* (R) 2+ years of experience in quality systems or regulatory compliance within a manufacturing or technical environment.
* (R) Working knowledge of ISO 9001:2015 and general quality management principles.
* (R) Experience with document control, CAPA systems, and audit processes.
* (R) Proficient in Microsoft Office (Excel, Word, PowerPoint) and quality management software.
Experience/Knowledge in this field (R/Required, P/Preferred):
* (R) Experience with root cause analysis tools (5 Whys, Fishbone, Pareto) and continuous improvement techniques (Lean, Six Sigma).
* (P) Experience with QMS software
* (P) Knowledge of ISO 14001 and 45001
General Experiences/Knowledge/Skills:
* Strong attention to detail, organization, and communication skills.
* Ability to work collaboratively and train/develop others
* Strong documentation
* Exceptional communication skills, demonstrated ability to communicate respectfully, culturally competent and collaboratively
* Excellent Ability to communicate in verbal, written and electronic forms in a professional manner when working with employees, vendors and company contacts
Quality Management System Manager
Posted 7 days ago
Job Viewed
Job Description
Position Summary: We are seeking a highly motivated and hands-on QMS Manager/Coordinator to upgrade and maintain Ouster's ISO9001/14001 QMS. Also, the QMS Manager/Coordinator will play a pivotal role in establishing our IATF 16949 Quality Management System. Working closely with an external consulting firm and various internal stakeholders, this position will be instrumental in driving our certification efforts and ensuring robust quality processes across all operations. The ideal candidate will be a proactive communicator, meticulous in documentation, and dedicated to fostering a culture of continuous improvement within an automotive manufacturing environment.
Key Responsibilities:
* IATF 16949 System Implementation Support:
* Act as the primary internal point of contact and liaison between the external IATF 16949 consultant and internal functional teams.
* Hands-on collaboration: Work directly with process owners (e.g., Engineering, Manufacturing, Purchasing, Logistics, Sales) to deeply understand current processes, identify gaps against IATF 16949 requirements, and facilitate the development of new, compliant procedures and work instructions.
* Lead and facilitate internal meetings and workshops with stakeholders to draft, review, and finalize QMS documentation (e.g., Quality Manual, Procedures, Forms, Records).
* Ensure all QMS documentation accurately reflects current operational practices and IATF 16949 standards, working to bridge theoretical requirements with practical application.
* Assist in the development and deployment of QMS training materials for employees across all levels.
* Support the consultant in preparing for all certification audits (readiness reviews, internal audits, stage 1 & 2 audits).
* Track progress of QMS implementation activities and report status to management and the external consultant.
* QMS Maintenance & Improvement:
* Support the ongoing maintenance of the QMS, including document control, record management, and system updates.
* Act as a liaison with external parties on matters relating to the quality management system
* Administer Corrective Action Request (CAR) program, including authorization and closeout of CARs
* Communicate and work effectively with all functional departments within the organization
* Communicate and work effectively with Customers, Suppliers and Auditors
* Develop/implement/champion policies, procedures and processes that improve product quality, reduce costs and improve productivity
* Develop/implement data collection methods to support process improvements and track quality-related business metrics
* Scheduling, conducting, and documenting internal audits to verify QMS effectiveness and compliance. Perform internal audits, provide audit results, and drive resolution of findings with the functional managers
* Support the management review process by compiling data and preparing reports on QMS performance for management reviews.
* Participate in continuous improvement initiatives related to the QMS and operational processes.
* Customer Quality Support:
* Act as a key support for all customer-related quality activities, ensuring timely and accurate responses.
* Assist with customer visits and audits, preparing necessary documentation and coordinating internal resources.
* Support the preparation and submission of customer-specific quality documentation (e.g., PPAP, APQP, FMEA, Control Plans, SPC data).
* Facilitate communication regarding customer complaints, quality issues, and corrective actions (8D reports), ensuring thorough investigation and resolution.
Qualifications:
* Bachelor's degree in Engineering, Quality Management, or a related technical field, or equivalent practical experience.
* 5-7 years of experience in a quality assurance or quality control role within a manufacturing environment, preferably automotive.
* Demonstrated understanding of Quality Management Systems, with foundational knowledge of ISO 9001 and/or IATF 16949 standards. (Direct IATF 16949 implementation experience is a strong plus, but not required given the consultant support.)
* Proven ability to read and interpret technical specifications, engineering drawings, and quality standards.
* Excellent written and verbal communication skills, with the ability to effectively collaborate with diverse teams, from shop floor personnel to senior management and external consultants.
* Strong organizational skills and meticulous attention to detail in documentation and record-keeping.
* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio/flowcharting tools).
* Proactive, self-starter with a strong sense of ownership and a problem-solving mindset.
* Ability to manage multiple tasks and priorities in a dynamic, fast-paced environment.
Preferred Qualifications (Nice to Have):
* Previous experience working directly on an IATF 16949 implementation project.
* Internal Auditor certification for ISO 9001 or IATF 16949.
* Familiarity with core automotive quality tools (APQP, PPAP, FMEA, SPC, MSA).
The base pay will be dependent on your skills, work experience, location, and qualifications. This role may also be eligible for equity & benefits. ($91,000-$168,000)
We acknowledge the confidence gap at Ouster. You do not need to meet all of these
requirements to be the ideal candidate for this role.
Ouster is an Equal Employment Opportunity employer that pursues and hires a diverse workforce. Ouster does not make employment decisions on the basis of race, color, religion, ethnic or national origin, nationality, sex, gender, gender-identity, sexual orientation, disability, age, military status, or any other basis protected by local, state, or federal laws. Ouster also strives for a healthy and safe workplace, and prohibits harassment of any kind. Pursuant to the San Francisco Fair Chance Ordinance, Ouster considers qualified applicants with arrest and conviction records for employment. If you have a disability or special need that requires accommodation, please let us know.
Quality Management System Specialist
Posted 7 days ago
Job Viewed
Job Description
Sponsorship Available: No
Relocation Assistance Available: No
Goodyear. More Driven.
About the Position
As the site's QMS Coordinator, this position is responsible for scheduling and facilitating internal quality audits, annual quality document reviews, annual management review, and external quality audits. This position will define and maintain a schedule of quality-related activities and deadlines and communicate with related teams to ensure we meet the schedule. This position will work closely with the QMS Engineer to prepare for external audits and implement QMS improvements. This position will also work with QMS associates throughout Goodyear to share best practices, implement global changes, and coordinate training.
With continuous improvement being a central part of our QMS system, this position will play a key support role in the GPGT capital process and quality improvement initiatives.
Primary Responsibilities
QUALITY MANAGEMENT: create and maintain a year-long QMS calendar, coordinate and facilitate internal audits (schedule meetings, lead audit prep, participate in audits, review reports, assist with non-conformance corrective actions, update status in QMS planner), facilitate CompliantPro document review (schedule and lead meetings, modify documents), facilitate the Quality Quiz (review and update questions/answers, send quiz to GPGT associates, compile and present results), conduct quality training for new associates and refresher training based on quiz results, support or co-lead internal auditor training, lead QMS planning meetings and Management Review meetings, attend the GPGT Council meeting monthly to give QMS updates
CONTINUOUS IMPROVEMENT: support site-wide quality improvement initiatives, collect and report quality metrics (corrective and preventive actions, audit findings and resolutions, etc.), ensure business processes that support quality and continuous improvement are aligned with related standards and process controls are being followed.
CAPITAL SPEND: collect capital SAP reports from Financial Records and Accounting, enter GPGT data into the PPIA capex tracking spreadsheet and monthly Finance X+Y forecast files on time, ensure project teams are accurately tracking expenses and projecting forecasted spend, remind project teams about accrual deadlines and assist with paperwork, review project justification forms for completeness prior to submitting to approvers.
Location: 11570 Noth US Highway 277 San Angelo, Texas.
Required Education and Experience
• Associate's degree, required.
• 3+ years of experience supporting corporate functions and teams.
• Experience following standards and procedures.
• Quality auditing experience preferred.
Skills and Abilities
• Attention to detail and effective time management and organization skills.
• Strong computer proficiency, particularly with Microsoft Excel, Powerpoint, Word, and Outlook.
• Strong communication and interpersonal skills when working with auditors, engineers, etc.
• Comfortable facilitating meetings with groups up to 10 people.
• Knowledge of ISO standards preferred.
About The Goodyear Tire & Rubber Company
Goodyear is one of the world's largest tire companies. It employs about 68,000 people and manufactures its products in 53 facilities in 20 countries around the world. Its two Innovation Centers in Akron, Ohio, and Colmar-Berg, Luxembourg, strive to develop state-of-the-art products and services that set the technology and performance standard for the industry. For more information about Goodyear and its products, go to
Goodyear is an Equal Employment Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to that individual's race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender identity, age, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.
If you need reasonable accommodation to complete the online application, or any other part of the employment process, please contact the Goodyear Candidate Care Line at .
Click here for more information about Equal Employment Opportunity laws, and here for additional supplementary information.
Quality Management System Specialist
Posted 7 days ago
Job Viewed
Job Description
Location:
San Angelo, TX, US
Company: Goodyear
Requisition ID: 125864
Sponsorship Available: No
Relocation Assistance Available: No
Goodyear. More Driven.
About the Position
As the site's QMS Coordinator, this position is responsible for scheduling and facilitating internal quality audits, annual quality document reviews, annual management review, and external quality audits. This position will define and maintain a schedule of quality-related activities and deadlines and communicate with related teams to ensure we meet the schedule. This position will work closely with the QMS Engineer to prepare for external audits and implement QMS improvements. This position will also work with QMS associates throughout Goodyear to share best practices, implement global changes, and coordinate training.
With continuous improvement being a central part of our QMS system, this position will play a key support role in the GPGT capital process and quality improvement initiatives.
Primary Responsibilities
QUALITY MANAGEMENT: create and maintain a year-long QMS calendar, coordinate and facilitate internal audits (schedule meetings, lead audit prep, participate in audits, review reports, assist with non-conformance corrective actions, update status in QMS planner), facilitate CompliantPro document review (schedule and lead meetings, modify documents), facilitate the Quality Quiz (review and update questions/answers, send quiz to GPGT associates, compile and present results), conduct quality training for new associates and refresher training based on quiz results, support or co-lead internal auditor training, lead QMS planning meetings and Management Review meetings, attend the GPGT Council meeting monthly to give QMS updates
CONTINUOUS IMPROVEMENT: support site-wide quality improvement initiatives, collect and report quality metrics (corrective and preventive actions, audit findings and resolutions, etc.), ensure business processes that support quality and continuous improvement are aligned with related standards and process controls are being followed.
CAPITAL SPEND: collect capital SAP reports from Financial Records and Accounting, enter GPGT data into the PPIA capex tracking spreadsheet and monthly Finance X+Y forecast files on time, ensure project teams are accurately tracking expenses and projecting forecasted spend, remind project teams about accrual deadlines and assist with paperwork, review project justification forms for completeness prior to submitting to approvers.
Location: 11570 Noth US Highway 277 San Angelo, Texas.
Required Education and Experience
* Associate's degree, required.
* 3+ years of experience supporting corporate functions and teams.
* Experience following standards and procedures.
* Quality auditing experience preferred.
Skills and Abilities
* Attention to detail and effective time management and organization skills.
* Strong computer proficiency, particularly with Microsoft Excel, Powerpoint, Word, and Outlook.
* Strong communication and interpersonal skills when working with auditors, engineers, etc.
* Comfortable facilitating meetings with groups up to 10 people.
* Knowledge of ISO standards preferred.
About The Goodyear Tire & Rubber Company
Goodyear is one of the world's largest tire companies. It employs about 68,000 people and manufactures its products in 53 facilities in 20 countries around the world. Its two Innovation Centers in Akron, Ohio, and Colmar-Berg, Luxembourg, strive to develop state-of-the-art products and services that set the technology and performance standard for the industry. For more information about Goodyear and its products, go to is an Equal Employment Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to that individual's race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender identity, age, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.
If you need reasonable accommodation to complete the online application, or any other part of the employment process, please contact the Goodyear Candidate Care Line at .
Click here for more information about Equal Employment Opportunity laws, and here for additional supplementary information.
Nearest Major Market: San Angelo
Nearest Secondary Market: Abilene
Job Segment: R&D Engineer, Internal Audit, ERP, SAP, Engineering, Finance, Quality, Technology
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Quality Management System Administrator
Posted 9 days ago
Job Viewed
Job Description
Company Spencer Aerospace Vacancy title Quality Management System Administrator Ref 31051 Location Senior Aerospace Spencer - 28510 Industry Dr, Valencia, CA 91355, USA Advertised salary $28.00/hr. Employment type Full-time Contract type Permanent/Regular Working pattern 8am - 5pm Closing date 17 August 2025 Description
Who is Senior plc?
Senior plc is an international, market-leading, engineering solutions provider with 26 operating businesses in 12 countries. Senior designs, manufactures and markets high-technology components and systems for the principal original equipment producers in the worldwide aerospace, defense, and land vehicle and power & energy markets. The Group is split into two divisions, Aerospace and Flexonics, servicing five key sectors.
Our global values underpin what we do, and how we do it .
Safety - Integrity - Customer Focus - Respect & Trust - Accountability - Excellence
Who is Senior Aerospace Spencer?
Senior Aerospace Spencer is an engineer-driven organization focused on high-pressure hydraulic fluid fittings for use in commercial and military aerospace applications. We specialize in source-controlled, standard, and proprietary fittings. Senior Aerospace Spencer also identifies solutions for fluid conveyance challenges related to fitting applications. Our engineering capabilities include conceptual design assistance, modeling, testing and qualification. Our senior engineering professionals are active members of the SAE G3 Fluid Fitting committee and are recognized industry-wide for their expertise.
What does the job involve?
The Quality Administrator will support the Quality Department in ensuring that all products meet required standards, regulatory guidelines, and customer expectations at our manufacturing facility. This includes maintaining approved supplier list, responding to customer surveys. Compling and auditing data associated to the Quality department and its processes to validate compliance of quality objectives, identify needs for improvement and/or preventative actions. Provide overall assistance in the maintenance of the quality system.
Essential Duties and Responsibilities:
- Maintain the Quality Management System by developing and revising procedures, work instructions, forms, charts and quality assurance reports.
- Maintain approved external provider matrix by performing assessments, provide, collect, validate and retain surveys.
- Support maintenance of training matrix, Issue, collect, and retain Training Activity Logs to ensure all employees are trained to the latest work instructions, policies and procedures.
- Customer Surveys: Prepare and complete by collecting, analyzing, and reporting data.
- Compile and evaluate Quality defect data to determine highest contributors and implement corrective and preventative action as determined.
- Support internal audits in compliance with the Audit Schedule, review all necessary documentation pertaining to the scheduled audit and its applicable areas, complete all Reports and Check Lists, provide leadership to personnel of area being audited, works with the Quality Director and/or Designee to ensure overall compliance to the Quality Management System.
- Create Quality KPI reports and perform data analysis. Create presentations as required.
- Assist with maintaining compliance of all calibrated assets.
- Provide support to Environmental Health & Safety activities.
- Other reasonable duties as business and operational needs dictate.
Education and/or Experience:
- High school diploma or equivalent.
- Some college (preferred)
- 1-2 years of Quality Management System experience and/or training or equivalent of education and experience.
Required Skills:
- Strong organizational skills
- Strong communication and interpersonal skills
- Excellent analytical and problem-solving abilities under pressure.
- Proficiency in quality testing techniques, tools, and software.
- Prior experience in a rapid growth environment.
- Openness to continued learning.
- Willingness to adapt to changing priorities, regulations or unexpected quality concerns
- Ability to manage high levels of stress, particularly when dealing with tight deadlines, production issues, or regulatory audits.
- Staying calm and focused under pressure while making critical decisions and maintaining high quality standards.
- Emotional resilience to handle the demands of managing multiple tasks and addressing quality failures in a fast-paced environment.
- Mental resilience to handle conflict resolution, particularly in cases where corrective actions or performance issues arise.
Physical Requirements:
Mobility & Flexibility: Ability to stand or walk for extended periods while performing inspections or audits on the production floor.
Lifting & Carrying : Occasional lifting of materials, products, or equipment, generally up to 25 pounds.
Manual Dexterity: Fine motor skills for documenting findings, using computers, or handling small parts during inspections.
Vision Requirements: Sharp visual acuity for close-up work such as reading technical documents, conducting visual inspections of products, and identifying defects.
Hearing & Communication: Adequate hearing to effectively communicate with employees and listen to machine sounds or alarms during production processes.Clear verbal communication to collaborate with production staff, management, and external auditors.
Working Conditions:
- Exposure to noise from machinery, requiring the use of hearing protection in some cases.
- Ability to work in environments with temperature fluctuations.
- Wearing personal protective equipment (PPE) such as safety glasses, steel-toed shoes, gloves, or hard hats as required in the facility.
If an offer of employment is made it will be contingent upon passing all of the following: Drug Test, Background Check, ITAR, and U.S. Export Compliance Screening.
Equal Opportunity Employer: minority/female/disability/veteran
ITAR Compliance:
Access to our facility (and, therefore, employment) is restricted under the International Traffic in Arms Regulations (ITAR) and/ or Export Administration Regulations (EAR) to U.S. Citizens, lawful permanent residents, U.S. refugees, asylees or temporary residents under amnesty provisions (as defined in 8 USC 1324b(a)(3)) and properly licensed foreign persons. Applicants receiving a conditional offer of employment will be required to provide information to determine whether they are subject to these regulations and, if so, to assess their country of chargeability for export control purposes. Additionally, potential employee's names will be screened against the Consolidated Screening List (maintained by the United States government) to determine eligibility to receive technical data.
#J-18808-LjbffrQuality Management System Administrator
Posted 3 days ago
Job Viewed
Job Description
In alignment with Gift of Life Michigan's core purpose and core values, the Quality Management System Administrator is responsible for administering and maintaining Gift of Life's electronic Quality Management System (QMS, currently Q-Pulse). This includes managing various modules and workflows, conducting system maintenance, and managing document reviews, which includes facilitating document training. Additionally, this position requires maintaining QMS resources and facilitating staff training.
Duties & ResponsibilitiesThe following job duties and responsibilities are stated in broad terms and not intended to be inclusive. Those in bold are essential duties of the position:
- Assume direct responsibility for managing, administering, and maintaining the QMS to ensure compliance with federal, state, accreditation and other third party legal and regulatory requirements and standards.
- Serve as the subject matter expert of the electronic QMS. Responsible for all administration and maintenance functions related to all Modules used by Gift of Life (i.e., Assets, Audits, Documents, People, Supplier, Training, Incident, Reporting Forms and Administration Modules).
- Create, edit and/or compile reports, records, checklists, managed lists, templates, and workflows.
- Create, edit, develop and/or compile various QMS reports for data analytics, tracking and trending.
- Manage user accounts, preferences, and security groups. Responsible for creating new users, disabling users, credentialing, and configuration management.
- Maintain and manage document records and approval templates. Support document workflows (i.e., creation, revision and archival) of controlled documents.
- Administer document trainings, complete training records, and facilitate training with end-users and new hires.
- Manage the annual review of controlled documents and collaborate with internal departments on proposed revisions to ensure compliance to regulatory requirements.
- Develop QMS reference documents, materials and job aids, etc. related to electronic quality management system functions to support end user needs. Additionally, develop various QMS reports for data analytics, tracking and trending.
- Support quality assurance and improvement initiatives, utilizing critical thinking skills to drive continuous improvement.
- Continuously evaluate electronic QMS platforms and or perform QSP functions to promote the evolution of the current electronic QMS.
- Perform other duties as assigned.
Required
- Associate degree in business, information technology, health sciences or a related field, and/or combination or education and experience.
- One year of quality or relevant document control experience.
- Experience with QMS such as, Q-Pulse software, or electronic systems administration.
- Prior experience successfully leading a project team, workgroup, etc.
- Experience fostering relationships and providing exemplary customer service to internal customers.
- Prior experience in a healthcare organization, transplant center, or organ/tissue procurement organization.
- Written and verbal fluency in English.
- Ability to exercise initiative, critical thinking, and problem-solving.
- Proficiency with Microsoft Office programs, including Outlook and Teams and other technology systems used in business operations.
- Strong organizational skills and ability to manage multiple and competing priorities.
- Demonstrate attention to detail.
- Knowledge of quality, quality improvement methodologies and the ability to apply appropriate quality tools and techniques.
- Strong presentation skills to audiences of varying backgrounds and sizes.
- Excellent verbal and written communication.
- Demonstrate the competencies of Professional, Determined and Compassionate.
- Maintain a motivated and positive attitude.
- Support an inclusive work environment.
- Ability to successfully collaborate and work as a member of an interdisciplinary team.
- Actively seek improvements.
- Always maintain a safe working environment and use of Universal Precautions.
- Maintain appropriate level of confidentiality in all areas dealing with sensitive, protected, and confidential information.
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Quality Management System Specialist

Posted 3 days ago
Job Viewed
Job Description
Sponsorship Available: No
Relocation Assistance Available: No
**Goodyear. More Driven.**
**About the Position**
As the site's QMS Coordinator, this position is responsible for scheduling and facilitating internal quality audits, annual quality document reviews, annual management review, and external quality audits. This position will define and maintain a schedule of quality-related activities and deadlines and communicate with related teams to ensure we meet the schedule. This position will work closely with the QMS Engineer to prepare for external audits and implement QMS improvements. This position will also work with QMS associates throughout Goodyear to share best practices, implement global changes, and coordinate training.
With continuous improvement being a central part of our QMS system, this position will play a key support role in the GPGT capital process and quality improvement initiatives.
**Primary Responsibilities**
QUALITY MANAGEMENT: create and maintain a year-long QMS calendar, coordinate and facilitate internal audits (schedule meetings, lead audit prep, participate in audits, review reports, assist with non-conformance corrective actions, update status in QMS planner), facilitate CompliantPro document review (schedule and lead meetings, modify documents), facilitate the Quality Quiz (review and update questions/answers, send quiz to GPGT associates, compile and present results), conduct quality training for new associates and refresher training based on quiz results, support or co-lead internal auditor training, lead QMS planning meetings and Management Review meetings, attend the GPGT Council meeting monthly to give QMS updates
CONTINUOUS IMPROVEMENT: support site-wide quality improvement initiatives, collect and report quality metrics (corrective and preventive actions, audit findings and resolutions, etc.), ensure business processes that support quality and continuous improvement are aligned with related standards and process controls are being followed.
CAPITAL SPEND: collect capital SAP reports from Financial Records and Accounting, enter GPGT data into the PPIA capex tracking spreadsheet and monthly Finance X+Y forecast files on time, ensure project teams are accurately tracking expenses and projecting forecasted spend, remind project teams about accrual deadlines and assist with paperwork, review project justification forms for completeness prior to submitting to approvers.
Location: 11570 Noth US Highway 277 San Angelo, Texas.
**Required Education and Experience**
- Associate's degree, required.
- 3+ years of experience supporting corporate functions and teams.
- Experience following standards and procedures.
- Quality auditing experience preferred.
**Skills and Abilities**
- Attention to detail and effective time management and organization skills.
- Strong computer proficiency, particularly with Microsoft Excel, Powerpoint, Word, and Outlook.
- Strong communication and interpersonal skills when working with auditors, engineers, etc.
- Comfortable facilitating meetings with groups up to 10 people.
- Knowledge of ISO standards preferred.
**About The Goodyear Tire & Rubber Company**
Goodyear is one of the world's largest tire companies. It employs about 68,000 people and manufactures its products in 53 facilities in 20 countries around the world. Its two Innovation Centers in Akron, Ohio, and Colmar-Berg, Luxembourg, strive to develop state-of-the-art products and services that set the technology and performance standard for the industry. For more information about Goodyear and its products, go to .
Goodyear is an Equal Employment Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to that individual's race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender identity, age, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.
If you need reasonable accommodation to complete the online application, or any other part of the employment process, please contact the Goodyear Candidate Care Line at .
Click for more information about Equal Employment Opportunity laws, and for additional supplementary information.
Quality Management System (QMS) Lead
Posted today
Job Viewed
Job Description
Kelly® Science & Clinical is seeking a QA QMS Lead for **a direct hire** position at **a CDMO in Sacramento, CA.** If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
**Salary:**
$75k-85k
**Overview** :
This company is dedicated to revolutionizing medication accessibility and affordability in North America by developing cost-effective generic prescription drugs and over-the-counter products, with a strong focus on excellence and integrity. By investing in its workforce's well-being and offering comprehensive benefits and training, the team drives innovation and positively impacts the healthcare industry.
In this role, you'll be responsible for managing and maintaining the Quality Management System (QMS), coordinating audits, analyzing quality data, and leading continuous improvement initiatives to ensure compliance with regulatory standards and high product quality within the pharmaceutical industry.
**Schedule:**
Monday-Friday, 8:30am to 5:00pm
**Responsibilities:**
+ Collect and analyze information to identify product and quality issues, collaborating with the Site Quality Lead Team for effective corrective and preventive actions.
+ Lead, mentor, and coach personnel in Change control, deviation management systems, and the CAPA program.
+ Conduct root cause investigations, assign corrective and preventive actions, and maintain the CAPA program cross-functionally.
+ Compile and present health metrics of the CAPA program and monitor deviation and CAPA performance for timely completion.
+ Provide instruction for Change control, Deviation Management, and CAPA courses, and support technical investigations.
+ Implement the electronic Quality Management System (eQMS) and engage in benchmarking best practices with the network deviation program mentor.
**Qualifications:**
+ Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or related field.
+ 3+ years of experience in in-process QA role within Pharmaceutical or GMP-regulated environment.
+ Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations
+ Proficiency in handling of electronic Quality Management systems (eQMS).
+ Experience in conducting root cause investigations, and execution of change management, investigating of deviation/non-conformance.
+ Ability to communicate effectively with customers to carry out requirements.
**What happens next:**
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry - even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Director Global Quality Management System
Posted 4 days ago
Job Viewed
Job Description
Date: Aug 16, 2025
Location(s):
Libertyville, IL, US, 60048-3781
Location(s):
Libertyville, IL, US, 60048-3781
Company: Hollister Incorporated
We Make Life More Rewarding and Dignified
Location: Libertyville
Department: Quality
Summary:
The Director, Global Quality Management System (QMS) is responsible for developing, implementing and sustaining a harmonized, world-class QMS across the organization. This role ensures global processes and systems are compliant with all applicable regulatory requirements and supports operational excellence across all sites. This role leads the enterprise-wide strategy to develop integrated & automated Quality Management System processes.
This role is responsible for the management and monitoring of the following QMS key processes: CAPA, Non-Conformances, Document Control, QMS related Training, Enterprise Wide QMS software solutions, Internal Audits, Global Management Reviews, QMS metrics and trending etc.
Hollister Incorporated operates in a hybrid work environment. For this position, we require the Associate to be onsite a minimum of 3 days per week.
Responsibilities:
* Ensures processes and systems within responsibility are compliant with all external and internal requirements.
* Ensures Quality Plans are developed and maintained when appropriate to drive implementation and/execution of initiatives while maintaining the effectiveness of the Quality Management System
* Responsible for early signal to management regarding concerns related to Global QMS.
* Drives QMS standardization/harmonization across sites as appropriate
* Works closely with site QMS/QA leads to ensure inputs and feedback on global QMS processes and systems is included to ensure smooth transition and implementation of actions per defined plans.
* Oversees the governance standardization and continuous improvement of key QMS processes.
* Collaborates with sites and regional stakeholders to ensure clear and proactive
* communication of changes for an effective change control.
* Identifies KPIs, tracks and monitors QMS performance metrics to identify trends and drive actions for continued improvements.
* Provides oversight and visibility of the performance of Hollister QMS
* Responsible for identifying systemic concerns and ensures appropriate investigation and action to address root cause as appropriate
* Shares lessons learned, near misses and best practices across sites for the areas of responsibility
* Leads readiness for regulatory inspections and ensure appropriate support for sites as needed.
* Responsible for identifying and maintaining global owners for global QMS policies and procedures including establishing responsibilities for these owners.
* Develops and communicate Quality Management enterprise-wide strategy, define budget requirements and resources
* Defines and implements performance metrics ensuring alignment with GQM strategy
* Leads, understands, champions and implements new regulations and guidelines to ensure compliance with applicable regulatory requirements and standards.
* Acts as a Corporate GQM Management Representative
* Responsible for implementing and maintaining an effective internal audit program for all Hollister sites within scope.
* Responsible for defining the risk management process for Quality Management System (not product related) to ensure issues are managed and prioritized accordingly.
* Defines plans and actions to drive high engagement within the team
* Responsible for effective talent management, development and succession planning for the area of responsibility.
Essential Function of the Role:
Communication/Leadership:
* Management of Talent Development and Employee Engagement
* Budget Management
* Strategic Planning and Deployment
* Ability to interface with a computer for a long period of time
* Public speaking requirements
* Significant reading requirements
* Constant utilization of listening skills, both person to person and over the phone
* Sitting for prolonged periods
* Talking
* Ability to travel domestically and internationally
Requirements:
* 12-15 years overall experience
* Minimum of 5 years of experience in medical device environment.
* Direct or hands on experience managing and implementing Quality Management Systems, CAPAs, Nonconformances, Internal Audit programs and Quality Management System Software and Validation.
* Direct experience managing external audits (Notify Body) and Inspections (FDA).
* Knowledge and experience managing and driving continuous improvement, identifying Key Performance Indicators and trending.
* Management experience driving talent and performance with direct and indirect reports. Experience in global, role matrix organization.
* Understanding of US and International Quality Systems regulations, including FDA cGMP and ISO 13485 and ISO 14971 Risk Management standards is required.
Education Requirements:
* Bachelor's degree required; MBA or MS preferred.
* Any or all of the following professional society certifications are desired, but not required:
* ASQ Certified Manager (CQM)
* ASQ Certified Quality Engineer (CQE)
* ASQ Certified Reliability Engineer (CRE)
* ASQ Certified Quality Auditor (CQA)
Specialized Skills/Technical Knowledge:
* Hands on experience ensuring compliance with: Quality Management system elements and associated regulatory requirements (ISO 13485, ISO 14971, CFR 21 FDA 820, MDD/MDR etc.) is required.
* Extensive experience working in Medical Devices.
* Experience with statistical sampling plans based on risk management.
* Greenbelt certification preferred with knowledge of Lean and Six Sigma methodologies required.
* Knowledge of ERP Systems preferred.
* Strong in Microsoft Office suite, especially Excel.
* Knowledge of internal & external audit management with proven experience in representing a company in interactions with notified body/Regulatory agencies.
* Working knowledge of continuous improvement and root cause problem solving in medical device.
* Demonstrated ability to project manage and execute tasks in a timely and efficient manner.
* Must be able to communicate (both written and verbal) at all levels of the organization and with customers, suppliers and regulatory agencies.
* Good interpersonal skills with the ability to work as part of a cross functional team.
* Excellent analytical skills with an ability to define problems, analyze through data collection/fact finding and draw valid conclusions in a timely manner.
* Fiscal Management
* Have a continuous improvement mindset and demonstrated change management skills.
* Fully fluent in English, verbal and written
#LI-Hybrid
Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.
* The anticipated base pay range for this position is $160,000 - $230,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
* This position is also eligible to participate in the Hollister Corporate Bonus Plan.
* The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
* The Company's 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions.
* The Company's paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
* The Company's additional benefits include: education assistance and adoption assistance benefit programs.
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.
EOE Statement
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.
Job Req ID: 34885
Job Segment: Internal Audit, Compliance, Law, Risk Management, Document Control, Finance, Legal, Administrative