9,109 Quality Assurance Director jobs in the United States

About Day and Zimmermann

No problem is too challenging or complex for Day & Zimmermann Maintenance and Construction (DZMC) because We do what we say! We're here to make life easier for plant owners in the Power, Chemical, and Industrial markets. With our wide-ranging capabilities and long-standing industry experience, we deliver innovative solutions and seamless processes that effectively manage all aspects of the plant life cycle. It's no wonder we're the #1 maintenance services provider in the United States. Come join in on our purpose - We put people to work, we protect American freedoms, and we help our customer's power and improve the world! Description

We're looking for a full-time, staff Director, Quality Assurance to join our Day & Zimmermann team.

Provide Quality Assurance management direction and oversight for QA programs including Nuclear, DOE, DoD, Solar and ISO programs.Manage all QA procedures and verify proper imlementation and address all related issues. Assures through oversight that Quality Assurance activities for the company and venders are defined, planned, implemented and documented in accordance with client, company and industry standards.

As the Director Quality Assurance, here's the work you'll do:

* Provide direction and oversight of QA Programs - DOE, DoD, Nuclear, Solar, ISO-9001
* Assures through oversight that Quality Assurance activities for the company and suppliers are defined, planned, implemented and documented in accordance with client, company and industry standards
* Establish and coordinates all audit activities for all business units and project organizations. This includes all vendor and supplier audits and maintain the corporate's Approved Supplier Lists.
* Coordinates activities to ensure that Quality Program budgets, schedules and priorities are met.
* Advises senior quality management and business unit managers of quality related deficiencies, audit findings, regulatory and third party inspection issues. Provides recommended resolution of the identified quality issues

This role is for you if you have these skills:

* Analytical ability to grasp key factors from detailed specifications
* Effective verbal communication and report writing skills
* Working knowledge of construction industry Codes and Standards - Welding Processes
* Good leadership capabilities to lead quality initiatives to successful completion
* Basic knowledge of applicable software to compile quality process data. Familiar with the tools, concepts and methodologies of quality management

And if you have these qualifications:

* College degree or equivalent experience
* 15 years Quality related experience
* Lead Auditor, Auditor Certification

In compliance with this state's pay transparency laws, the salary range for this role is $124,080 - $186,120. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. (The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements).

We care about our employees, and it shows. Our staff receive a competitive salary and a comprehensive benefits package which includes medical/Rx, dental and vision coverage; life, AD&D and disability insurance; flexible spending accounts; 100% paid maternity leave for up to 12 weeks, parental leave, family leave, other paid time off; voluntary benefits and discount programs to meet our employees' individual needs including pet insurance for our furry family members!

To ensure a safe work environment while meeting the physical demands of the job, you must be able to perform the following physical and mental tasks, with or without a reasonable accommodation:

* Visual acuity (e.g., needed to prepare and analyze data, to transcribe documents, to view a computer, to read, to inspect objects, to operate machinery • Balancing (e.g., maintaining equilibrium when walking, climbing, crouching etc.) • Stooping (e.g., bending the spine at the waist) • Walking • Kneeling, crouching or crawling • Manual Dexterity (e.g. picking, pinching, typing, or other working that uses fingers) • Grasping (e.g., use of hand of apply pressure) • Feeling (e.g. perceiving an object's size, shape, texture etc.) • Climbing (e.g. ascending/descending ladders, stair, scaffolding, ramps, pole etc. using feet and legs or hands/arms to climb) • Hearing • Talking • Capacity to think, concentrate and focus over long periods of time • Ability to read/write complex documents in the English language • Capacity to reason and make sound decisions • Capacity to express thoughts orally • Ability to regularly perform all job functions at company's office or work site • Travel required 30%

SO WHAT ARE YOU WAITING FOR? APPLY NOW! Talent Acquisition Partner: Ashley Mitchell

Diversity, Inclusion & Equal Employment Opportunity

Day & Zimmermann is committed to maintaining an inclusive workforce, where employees are hired, retained, compensated and promoted based on their contributions to our Company. Our collective strength is rooted in over a century of diverse employees and businesses, commitment to success, and delivery on promises made. Federal and state Equal Employment Opportunity laws prohibit employment discrimination based on race, color, religion, sex, sexual orientation, age, national origin, citizenship status, veteran status and disability status. Day & Zimmermann is committed to providing an equal opportunity work environment in full compliance with these laws. If you are an individual with a disability and you require an accommodation in the application process, please email , and please specify which position you are interested in, including job title and location.

Connect with us:

Nearest Major Market: Charlotte

Cerro Flow Products LLC

As a part of the global industrial organization Marmon Holdings-which is backed by Berkshire Hathaway-you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.

Establishes and maintains procedures and techniques for control of quality standards & multiple plant responsibilities. Assists in the coordination of manufacturing and engineering and confers with customers to define and resolve product quality issues.

Establishes and maintains procedures and techniques for control of quality standards & multiple plant responsibilities. Assists in the coordination of manufacturing and engineering and confers with customers to define and resolve product quality issues.

Job Title: Quality Assurance Director

Location: Sauget, Illinois

Employment Type: Full-Time

Salary Range: $135,000.00-$145,000.00

Who We Are: Cerro Flow Products, LLC, part of Marmon Holdings-a Berkshire Hathaway company, has proudly delivered "Made in the USA" copper and brass flow control products for over 80 years. As part of a global organization with over 125 autonomous businesses, we serve the Plumbing, HVAC/R, and Industrial markets with a focus on innovation, customer satisfaction, and cost efficiency. Known for our quality and reliability, we also provide exceptional sales support and product expertise.

Position Overview: The Quality Assurance Director is responsible for leading the development, implementation, and continuous improvement of the organization's Quality Management System (QMS). This role ensures compliance with industry standards and regulatory requirements while driving operational excellence across all functions. Additionally, the Director serves as a strategic resource for ERP system integration, supporting teams in aligning ERP capabilities with quality processes. The Quality and Continuous Improvement Partner reports directly to this position, contributing to initiatives that enhance organizational efficiency and performance.

Responsibilities:

* Lead and enhance the company's Quality Management System (QMS) to ensure robust compliance and performance.
* Ensure adherence to applicable standards and regulations, including ISO and GMP.
* Provide strategic guidance on ERP system utilization as it relates to quality processes and data integrity.
* Collaborate cross-functionally to align ERP tools with operational and quality objectives.
* Oversee internal and external audits, manage corrective actions, and conduct risk assessments.
* Supervise the Quality and CI Partner, driving continuous improvement initiatives.
* Analyze quality and ERP data to identify trends and recommend process optimizations.
* Develop and deliver training programs on quality procedures and ERP best practices.
* Maintain comprehensive documentation and reporting for quality and compliance activities.

Qualifications:

* Bachelor's degree in quality management, Engineering, Business Administration, or a related field. Or equivalent experience
* Extensive experience in quality systems and regulatory compliance.
* Proficiency with ERP platforms such as SAP, Oracle, or Microsoft Dynamics, and their integration with quality functions.
* Demonstrated leadership and team management capabilities.
* Strong communication, analytical, and problem-solving skills.
* Experience with Lean, Six Sigma, or other continuous improvement methodologies is preferred.

Why Join Cerro: Be part of a dynamic, collaborative team where great people come together to achieve remarkable results. At Cerro Flow Products, we believe in fostering a workplace built on diversity, inclusion, and positivity. Our culture celebrates teamwork, innovation, and shared success, creating an environment where every employee feels valued and empowered to thrive.

Why Join Us?

We are proud to offer a competitive and comprehensive benefits package designed to support the well-being and success of our employees. Our offerings include:

* Medical, Dental, and Vision Insurance - Quality coverage to keep you and your family healthy.
* 401(k) Retirement Plan with Company Match - Helping you plan for your future.
* Paid Time Off (PTO) - Generous vacation, sick leave, and holiday pay.
* Short-Term and Long-Term Disability Insurance (STD/LTD) - Financial protection when you need it most.
* Life Insurance - Peace of mind for you and your loved ones.
* Employee Assistance Program (EAP) - Confidential support for personal and professional challenges.
* Tuition Reimbursement - Invest in your education and career growth.
* Health Savings Account (HSA) - Tax-advantaged savings for medical expenses.
* Exclusive Company Discounts - Savings on products and services.

At Cerro, your ideas and contributions matter, and together, we build a workplace that inspires growth, creativity, and excellence. Join us and make a meaningful impact while building connections with colleagues who share your dedication and enthusiasm.

Pay Range:

112,000.00 - 168,000.00

We offer a comprehensive benefits package that may include medical, dental, vision, 401k matching, and more!

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.

POSITION SUMMARY:

This position reports to the Senior Director, Quality Assurance and will independently manage the Quality aspects of commercial and clinical drug manufacturing, validation, and operations at the contract manufacturers. This position is responsible for the management, operation, and upkeep of the Quality Assurance activities and support Inspection readiness activities for GxP (GMP, GLP, & GCP) programs. This position is also responsible for assistance in vendor oversight and day to-day QA operations and fosters a culture of continuous improvement in all aspects of GxP Quality, including the development and administration of policies and practices that address quality issues throughout the organization and enhancement of electronic systems and new technologies.

Salary Range:

National $185,000 - $15,000

Premium (NY/CA) 200,000 - 240,000

ESSENTIAL DUTIES AND RESPONSIBILITIES:

* Perform quality oversight of cGMP activities which include independently setting up and/or optimizing processes for, drug substance and drug product manufacturing, labeling, batch record review and lot disposition
* Provide direction for complex deviations and other investigations and CAPAs in support of batch release, inspection readiness and regulatory findings including tracking closure of compliance issues
* Independently perform and/or manage batch release activities for commercial and clinical production including but not limited to review of batch records, analytical data, certificates of analysis, and other documents (e.g., method validation protocols/reports, product specifications, change controls, etc.) as needed for consistency with applicable regulations and for compliance with company's GMP Quality System
* Provide status reports, including relevant quality metrics and participate in the management review process
* Identify and support continuous improvement projects in collaboration with CMC, QC and RA to achieve quality, reliability and efficiency improvement objectives
* Support or lead implementation and upgrades of digital tools and systems supporting Quality
* Manage quality assurance team and consultants, as assigned
* Establish collaborative relationships with internal and external stakeholders to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner
* Establish internal SOPs applicable to internal functions as well as outsourced functions
* Assist in any Regulatory inspections readiness
* Establish and ensure that policies at Rigel and CMOs adhere to cGMPs, and regulatory requirements of FDA, EMA and other regulatory agencies as required
* Oversee QA Review of process validation protocols, validation data and validation reports
* Provide quality assurance support in the technology transfer, scale-up, validation and manufacturing at CMO.
* Manage assigned QA operation tasks in accordance with Rigels SOPs (e.g., trending report, training program)
* Independently interact with other groups to proactively address compliance concerns and resolve problems
* Able to participate in cross-functional compliance improvement projects
* Perform internal and external audits
* · Able to work with electronic and paper-based systems

ADDITIONAL RESPONSIBILITIES:

* Perform Annual Product Reviews
* Ability to file Field Alert Reports (FAR)
* Develop Quality Management Systems

KNOWLEDGE AND SKILL REQUIREMENTS:

* Minimum BS/BA in Chemistry, Biology or other relevant discipline
* 12+ years QA or equivalent experience in the Pharmaceuticals/ or Pharma and Device, and at least 4 years of leadership and management experience
* Prior hands-on experience establishing and/or maintaining a document control system is required. Experience with implementing new technologies is preferred.
* Prior working experience maintaining training program activities
* Strong understanding of cGMPs (21 CFR 210, 211), ICH guidelines and ISO concepts
* Understanding of basic scientific/technical concepts
* Good analytical skills
* Clear, concise writing skills and good verbal presentation skills. Including but not limited to Word, Excel, MS Office and SharePoint
* Excellent organizational skills and attention to detail
* Ability to interact constructively and efficiently with co-workers
* Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors
* Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
* Demonstrates strong understanding of procedures and methods for review function
* PAI readiness or BIMO readiness are preferred
* Ability to work under tight deadlines
* May participate on project teams and actively participate in cross-functional compliance improvement projects
* Works under only general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives
* Hands-on experience and proficiency in writing Deviations, Change controls, CAPAs, Investigations, SOPs and other controlled documents

WORKING CONDITIONS:

* PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
* WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

Apply

Description

GENERAL SUMMARY

Coordinates/Leads the Agency's Continuous Quality/Performance Improvement to ensure a proactive approach to the revision, provision and development of treatment services that meet or exceed compliance with accrediting standards (CARF), other regulatory bodies and the Agency's strategic plans. Ensures Agency's required codes of ethics and values are practiced in daily operations.

* MINIMUM QUALIFICATIONS

Master's in Behavioral Health Science with 3 years of experience in Quality Improvement and Accreditation

And/or Bachelor's Degree in Behavioral Health Science with 5 years of experience both required to have CARF survey experience.

Requirements

I. Coordinate and facilitate the Agency-wide Quality Improvement Program including but not limited to:

* Collaborates with the Clinical Quality Assurance Director to ensure that there is a written annual plan for the Quality Improvement Plan which describes the Agency's performance goals, areas needing improvement, strategies to achieve, and ongoing mechanisms to review, renew, or revise goals, strategy or tactics.
* Develops/revises Agency-wide written policy and procedures, other documents, written plans as required by external accreditation or other regulatory entities. Ensures Agency stays informed of changes and remains current and in compliance with all regulatory requirements.
* Chairs the Quality Improvement Committee and oversees all sub committees. Continually monitors and evaluates the Quality Improvement program and implements corrective actions as needed to achieve optimal outcomes.
* Chairs the Recovery Oriented System of Care Committee. Collaborates with the Clinical Quality Assurance Director to facilitate internal ROSC chart audits and client interviews.
* Provides direction to various Agency departmental groups with regard to their respective Quality Improvement activities, monitors compliance and reports deficiencies to QI Committee.
* Serves as the central coordinating point for all contract monitoring, corrective action and performance improvement plans.
* Collaborates with the Clinical Director and Information Technology Director to develop and maintain automated databases for Quality/Performance and accreditation data; provides periodic statistical and summary reports as required.
* Oversees Risk Management/ Facilities and Safety
* Responsible for agency licensing renewals

II. Participates in all Agency Quality Improvement committees and sub-committees as directed:

* Provides directions for the continuous Quality Improvement committee as appropriate.
* In conjunction with the appropriate Quality Improvement committee(s), continually reviews data related to service delivery in order to determine committee agenda(s) and identifying areas requiring further support, training, review or revision.
* Tracks, monitors the status of identified problems to ensure their improvement or resolution.
* Maintains Quality Improvement tracking systems for all committee meetings reflecting issues discussed recommended action, follow-up status and the designated party (ies) responsible for the appropriate follow-up.

III. Coordinates, Coordinates, gathers, disseminates and documents information to facilitate compliance with requirements for accreditation surveys and other regulatory and contract entities:

* Effectively plans and coordinates the preparation of on-site accreditation and monitoring surveys.
* Demonstrates effectiveness in presenting and/or providing information to program managers, as needed, to assure compliance with accreditation/statutory/contract requirements and/or standards.
* Provides assistance to staff in monitoring and evaluating the performance of care in their respective programs; assists in the development and revision of policies as required and/or indicated.
* Maintains current knowledge of accreditation standards and the survey process for the Commission on Accreditation of Rehabilitation Facilities (CARF).
* Effectively provides ongoing information to management on Quality/Performance activities and provides timely status reports on accreditation preparedness, CAPs and other related issues.
* This position will oversee the staff who is assigned as the official Single Point of Contact, which is designated to coordinate the provision of auxiliary aids and services to the deaf and hard of hearing.

IV. Participates in the Corporate Compliance Program for the Organization.

* Assists with audit procedures are implemented in accordance with New Horizons' audit policies.
* Assists with investigations of client/employee complaints/grievances and other concerns regarding compliance, as requested.
* Participates in administrative committees and meetings and community relations activities.

V. Coordinates, gathers and analyzes all client grievances for the agency:

* Ensures that all grievances are entered into the EHR System.
* Reviews grievances, communicates with individuals who submit the grievances, and assigns them to a manager to be reviewed.
* Ensures that all necessary time frames are complied with.
* Identifies any trends within the grievances and provides additional training when necessary.
* Reports monthly on compiled information to appropriate Quality Improvement sub-committee and recommends any follow up necessary.

VI. Supervises Medical Records Staff:

* Demonstrates knowledge of the legal aspects, including the liabilities of patient/client medical records.
* Demonstrates an understanding of the laws pertaining to confidentiality and the release of medical records information ensuring that agency policies and procedures are within the legal boundaries and guidelines as established by applicable Florida Statute(s) and Administrative Code(s) and the Federal Substance Abuse Regulations.
* All "on the job" and "off the job" activities are performed in accordance with the Agency's Client Confidentiality standards.
* Works with and supervises Medical Records Staff, providing leadership and direction as needed.

VII. Serves as the Privacy Officer for the agency as required under Health Information Portability and Accountability Act (HIPAA)

* Receives and responds to complaints regarding potential violations of confidentiality and provides additional information as required.
* Works cooperatively with various Agency departments after receiving notices requesting to inspect, amend, and restrict access to protected health information and provides additional information as required.
* Develop and implement the Agency's privacy policy and procedures
* Performs periodic privacy monitoring activities.
* Provides the initial privacy training as part of orientation to all employees.
* Works with management, key departments, and committees to ensure the organization has and maintains appropriate privacy and confidentiality consent, authorization forms, and privacy notices that reflect current legal practices and requirements.
* Participates in the development, implementation, and ongoing compliance monitoring of all business associate agreements, to ensure all privacy concerns, requirements, and responsibilities are addressed.

VIII. Oversees Internal Incident Reporting and Analysis System (IRAS) process

* Oversees all Grievances
* Submits timely reporting into States IRAS/CARF database
* Follows up on inquiries and questions from SEFBHN/DCF regarding IRAS submissions in a timely manner.
* Follows up with Program Managers on follow up actions and performance improvements plans when appropriate.
* Tracks trends and reports to Quality Assurance committee.
* Makes necessary policy revisions or suggested trainings from IR date

About Day and Zimmermann

No problem is too challenging or complex for Day & Zimmermann Maintenance and Construction (DZMC) because We do what we say! We're here to make life easier for plant owners in the Power, Chemical, and Industrial markets. With our wide-ranging capabilities and long-standing industry experience, we deliver innovative solutions and seamless processes that effectively manage all aspects of the plant life cycle. It's no wonder we're the #1 maintenance services provider in the United States. Come join in on our purpose - We put people to work, we protect American freedoms, and we help our customer's power and improve the world! Description

We're looking for a full-time, staff Director, Quality Assurance to join our Day & Zimmermann team.

Provide Quality Assurance management direction and oversight for QA programs including Nuclear, DOE, DoD, Solar and ISO programs.Manage all QA procedures and verify proper imlementation and address all related issues. Assures through oversight that Quality Assurance activities for the company and venders are defined, planned, implemented and documented in accordance with client, company and industry standards.

As the Director Quality Assurance, here's the work you'll do:

* Provide direction and oversight of QA Programs - DOE, DoD, Nuclear, Solar, ISO-9001
* Assures through oversight that Quality Assurance activities for the company and suppliers are defined, planned, implemented and documented in accordance with client, company and industry standards
* Establish and coordinates all audit activities for all business units and project organizations. This includes all vendor and supplier audits and maintain the corporate's Approved Supplier Lists.
* Coordinates activities to ensure that Quality Program budgets, schedules and priorities are met.
* Advises senior quality management and business unit managers of quality related deficiencies, audit findings, regulatory and third party inspection issues. Provides recommended resolution of the identified quality issues

This role is for you if you have these skills:

* Analytical ability to grasp key factors from detailed specifications
* Effective verbal communication and report writing skills
* Working knowledge of construction industry Codes and Standards - Welding Processes
* Good leadership capabilities to lead quality initiatives to successful completion
* Basic knowledge of applicable software to compile quality process data. Familiar with the tools, concepts and methodologies of quality management

And if you have these qualifications:

* College degree or equivalent experience
* 15 years Quality related experience
* Lead Auditor, Auditor Certification

In compliance with this state's pay transparency laws, the salary range for this role is $124,080 - $186,120. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. (The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements).

We care about our employees, and it shows. Our staff receive a competitive salary and a comprehensive benefits package which includes medical/Rx, dental and vision coverage; life, AD&D and disability insurance; flexible spending accounts; 100% paid maternity leave for up to 12 weeks, parental leave, family leave, other paid time off; voluntary benefits and discount programs to meet our employees' individual needs including pet insurance for our furry family members!

To ensure a safe work environment while meeting the physical demands of the job, you must be able to perform the following physical and mental tasks, with or without a reasonable accommodation:

* Visual acuity (e.g., needed to prepare and analyze data, to transcribe documents, to view a computer, to read, to inspect objects, to operate machinery • Balancing (e.g., maintaining equilibrium when walking, climbing, crouching etc.) • Stooping (e.g., bending the spine at the waist) • Walking • Kneeling, crouching or crawling • Manual Dexterity (e.g. picking, pinching, typing, or other working that uses fingers) • Grasping (e.g., use of hand of apply pressure) • Feeling (e.g. perceiving an object's size, shape, texture etc.) • Climbing (e.g. ascending/descending ladders, stair, scaffolding, ramps, pole etc. using feet and legs or hands/arms to climb) • Hearing • Talking • Capacity to think, concentrate and focus over long periods of time • Ability to read/write complex documents in the English language • Capacity to reason and make sound decisions • Capacity to express thoughts orally • Ability to regularly perform all job functions at company's office or work site • Travel required 30%

SO WHAT ARE YOU WAITING FOR? APPLY NOW! Talent Acquisition Partner: Ashley Mitchell

Diversity, Inclusion & Equal Employment Opportunity

Day & Zimmermann is committed to maintaining an inclusive workforce, where employees are hired, retained, compensated and promoted based on their contributions to our Company. Our collective strength is rooted in over a century of diverse employees and businesses, commitment to success, and delivery on promises made. Federal and state Equal Employment Opportunity laws prohibit employment discrimination based on race, color, religion, sex, sexual orientation, age, national origin, citizenship status, veteran status and disability status. Day & Zimmermann is committed to providing an equal opportunity work environment in full compliance with these laws. If you are an individual with a disability and you require an accommodation in the application process, please email , and please specify which position you are interested in, including job title and location.

Connect with us:

Nearest Major Market: Charlotte

About Day and Zimmermann

No problem is too challenging or complex for Day & Zimmermann Maintenance and Construction (DZMC) because We do what we say! We're here to make life easier for plant owners in the Power, Chemical, and Industrial markets. With our wide-ranging capabilities and long-standing industry experience, we deliver innovative solutions and seamless processes that effectively manage all aspects of the plant life cycle. It's no wonder we're the #1 maintenance services provider in the United States. Come join in on our purpose - We put people to work, we protect American freedoms, and we help our customer's power and improve the world! Description

We're looking for a full-time, staff Director, Quality Assurance to join our Day & Zimmermann team.

Provide Quality Assurance management direction and oversight for QA programs including Nuclear, DOE, DoD, Solar and ISO programs.Manage all QA procedures and verify proper imlementation and address all related issues. Assures through oversight that Quality Assurance activities for the company and venders are defined, planned, implemented and documented in accordance with client, company and industry standards.

As the Director Quality Assurance, here's the work you'll do:

* Provide direction and oversight of QA Programs - DOE, DoD, Nuclear, Solar, ISO-9001
* Assures through oversight that Quality Assurance activities for the company and suppliers are defined, planned, implemented and documented in accordance with client, company and industry standards
* Establish and coordinates all audit activities for all business units and project organizations. This includes all vendor and supplier audits and maintain the corporate's Approved Supplier Lists.
* Coordinates activities to ensure that Quality Program budgets, schedules and priorities are met.
* Advises senior quality management and business unit managers of quality related deficiencies, audit findings, regulatory and third party inspection issues. Provides recommended resolution of the identified quality issues

This role is for you if you have these skills:

* Analytical ability to grasp key factors from detailed specifications
* Effective verbal communication and report writing skills
* Working knowledge of construction industry Codes and Standards - Welding Processes
* Good leadership capabilities to lead quality initiatives to successful completion
* Basic knowledge of applicable software to compile quality process data. Familiar with the tools, concepts and methodologies of quality management

And if you have these qualifications:

* College degree or equivalent experience
* 15 years Quality related experience
* Lead Auditor, Auditor Certification

In compliance with this state's pay transparency laws, the salary range for this role is $124,080 - $186,120. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. (The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements).

We care about our employees, and it shows. Our staff receive a competitive salary and a comprehensive benefits package which includes medical/Rx, dental and vision coverage; life, AD&D and disability insurance; flexible spending accounts; 100% paid maternity leave for up to 12 weeks, parental leave, family leave, other paid time off; voluntary benefits and discount programs to meet our employees' individual needs including pet insurance for our furry family members!

To ensure a safe work environment while meeting the physical demands of the job, you must be able to perform the following physical and mental tasks, with or without a reasonable accommodation:

* Visual acuity (e.g., needed to prepare and analyze data, to transcribe documents, to view a computer, to read, to inspect objects, to operate machinery • Balancing (e.g., maintaining equilibrium when walking, climbing, crouching etc.) • Stooping (e.g., bending the spine at the waist) • Walking • Kneeling, crouching or crawling • Manual Dexterity (e.g. picking, pinching, typing, or other working that uses fingers) • Grasping (e.g., use of hand of apply pressure) • Feeling (e.g. perceiving an object's size, shape, texture etc.) • Climbing (e.g. ascending/descending ladders, stair, scaffolding, ramps, pole etc. using feet and legs or hands/arms to climb) • Hearing • Talking • Capacity to think, concentrate and focus over long periods of time • Ability to read/write complex documents in the English language • Capacity to reason and make sound decisions • Capacity to express thoughts orally • Ability to regularly perform all job functions at company's office or work site • Travel required 30%

SO WHAT ARE YOU WAITING FOR? APPLY NOW! Talent Acquisition Partner: Ashley Mitchell

Diversity, Inclusion & Equal Employment Opportunity

Day & Zimmermann is committed to maintaining an inclusive workforce, where employees are hired, retained, compensated and promoted based on their contributions to our Company. Our collective strength is rooted in over a century of diverse employees and businesses, commitment to success, and delivery on promises made. Federal and state Equal Employment Opportunity laws prohibit employment discrimination based on race, color, religion, sex, sexual orientation, age, national origin, citizenship status, veteran status and disability status. Day & Zimmermann is committed to providing an equal opportunity work environment in full compliance with these laws. If you are an individual with a disability and you require an accommodation in the application process, please email , and please specify which position you are interested in, including job title and location.

Connect with us:

Nearest Major Market: Charlotte

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin?

• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Job Scope

The Quality Assurance Director is responsible for leading and maintaining the Quality Management System (QMS) for the DiaSorin Molecular business unit, ensuring full compliance with all applicable regulatory requirements, including but not limited to FDA, ISO 13485, IVDD/IVDR, CMD/CAS, and relevant federal, state, and local regulations. This individual serves as the designated Management Representative and provides strategic oversight of the QMS with a focus on Operational Quality, ensuring its effective implementation and continuous improvement in alignment with both local and international regulatory expectations.

Key Duties and Responsibilities

• Quality System Oversight:
  • Manage and continuously improve the QMS to align with lean manufacturing principles, ensuring it supports product quality, operational efficiency, and regulatory compliance. Lead cross-functional quality initiatives that drive measurable improvements in compliance, productivity, and risk mitigation.
• Regulatory Compliance:
  • Serve as the primary point of contact for regulatory inspections and audits. Maintain up-to-date knowledge of applicable regulations and ensure organizational practices remain compliant. Lead efforts to identify and address compliance gaps proactively.
• Manufacturing Quality & Process Excellence:
  • Provide expert-level technical analysis of product development and manufacturing processes to ensure conformance to specifications and quality standards. Leverage root cause analysis, statistical methods, and lean tools (e.g., FMEA, 5 Whys, value stream mapping) to drive process improvements and reduce non-conformances.
• Training & Leadership:
  • Mentor and develop junior Quality Engineers, fostering a culture of quality, accountability, and continuous improvement. Champion training initiatives to enhance technical competencies and regulatory knowledge across the Quality team.
• Project Participation:
  • Actively participate in cross-functional project teams, representing Quality functions for the Chicago site. Ensure compliance with Design Control requirements throughout the product lifecycle, from concept through commercialization.
• CAPA & Risk Management:
  • Lead and support the execution of Corrective and Preventive Actions (CAPA), ensuring root cause investigations are thorough and utilize appropriate quality tools. Promote a data-driven approach to risk identification, analysis, and mitigation in both development and manufacturing environments.
• Validation & Documentation:
  • Oversee validation planning and execution for manufacturing processes, equipment, and software. Ensure all validation activities are appropriately documented in compliance with internal procedures and external regulatory requirements.
  • Act as Management Representative and IVDR Person Responsible for Regulatory Compliance (PRRC) for the site. In this capacity, ensure that product meets label claims and customer satisfaction, any quality or regulatory issue is elevated to the DiaSorin Molecular President and/or DiaSorin S.p.A Head of Corporate Quality/Regulatory, and oversee and drive continuous improvement of the Quality Systems.
• Among additional duties, the main responsibilities are as detailed in Article 15 of the EU IVDR 2017/746:
• Perform other duties as assigned.

Education, Experience, and Qualifications

• Bachelor's Degree or relevant field required. Examples could be Engineering or life sciences discipline such as Mechanical, Electrical, Industrial, Manufacturing Engineering, Bioengineering, and/or Quality Engineering.
• Master's degree or relevant field preferred. Examples could be Engineering or life sciences discipline such as Mechanical, Electrical, Industrial, Manufacturing Engineering, Bioengineering, and/or Quality Engineering.
• Minimum 7+ Years management experience in medical device industry, IVD experience
• 5+ Years experience to include at least five years of experience in quality management.
• Specific Licenses and Certifications Preferred: ASQ Certified Quality Engineer, Lean Six Sigma Black Belt, Certified Quality or Biomedical Auditor a plus, but not required.

Training and Skills

• Thorough knowledge of International, Federal, State, FDA regulations and ISO 13485 Quality Management Systems is required.
• Must have a thorough understanding and experience in software lifecycle and validation requirements.
• FDA Product and Process Validation Techniques.
• Must be proficient in Microsoft Word, Microsoft Excel and Microsoft PowerPoint.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of top management, public groups, managers, clients, and customers.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.

What we offer

The salary range for this position is $151,200 - $216,000 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, education, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial well-being, time off programs, well-being support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at or 1- to request an accommodation.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.

About Day and Zimmermann

No problem is too challenging or complex for Day & Zimmermann Maintenance and Construction (DZMC) because We do what we say! ® We're here to make life easier for plant owners in the Power, Chemical, and Industrial markets. With our wide-ranging capabilities and long-standing industry experience, we deliver innovative solutions and seamless processes that effectively manage all aspects of the plant life cycle. It's no wonder we're the #1 maintenance services provider in the United States. Come join in on our purpose - We put people to work, we protect American freedoms, and we help our customer's power and improve the world!

Position Description

We're looking for a full-time, Director, Quality Assurance to join our Day & Zimmermann team.

Provide Quality Assurance management direction and oversight for QA programs including Nuclear, DOE, DoD, Solar and ISO programs.Manage all QA procedures and verify proper imlementation and address all related issues. Assures through oversight that Quality Assurance activities for the company and venders are defined, planned, implemented and documented in accordance with client, company and industry standards.

As the Director Quality Assurance, here's the work you'll do:

• Provide direction and oversight of QA Programs - DOE, DoD, Nuclear, Solar, ISO-9001
• Assures through oversight that Quality Assurance activities for the company and suppliers are defined, planned, implemented and documented in accordance with client, company and industry standards
• Establish and coordinates all audit activities for all business units and project organizations. This includes all vendor and supplier audits and maintain the corporate's Approved Supplier Lists.
• Coordinates activities to ensure that Quality Program budgets, schedules and priorities are met.
• Advises senior quality management and business unit managers of quality related deficiencies, audit findings, regulatory and third party inspection issues. Provides recommended resolution of the identified quality issues

This role is for you if you have these skills:

• Analytical ability to grasp key factors from detailed specifications
• Effective verbal communication and report writing skills
• Working knowledge of construction industry Codes and Standards - Welding Processes
• Good leadership capabilities to lead quality initiatives to successful completion
• Basic knowledge of applicable software to compile quality process data.
• Familiar with the tools, concepts and methodologies of quality management

And if you have these qualifications:

• College degree or equivalent experience
• 15 years Quality related experience
• Lead Auditor, Auditor Certification

In compliance with this states pay transparency laws, the salary range for this role is $124,080 - $186,120. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. (The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements)

We care about our employees, and it shows. Our staff receive a competitive salary and a comprehensive benefits package which includes medical/Rx, dental and vision coverage; life, AD&D and disability insurance; flexible spending accounts; 100% paid maternity leave for up to 12 weeks, parental leave, family leave, other paid time off; voluntary benefits and discount programs to meet our employees individual needs including pet insurance for our furry family members!

To ensure a safe work environment while meeting the physical demands of the job, you must be able to perform the following physical and mental tasks, with or without a reasonable accommodation:

• Visual acuity (e.g., needed to prepare and analyze data, to transcribe documents, to view a computer, to read, to inspect objects, to operate machinery
• Balancing (e.g., maintaining equilibrium when walking, climbing, crouching etc.)
• Stooping (e.g., bending the spine at the waist)
• Walking
• Kneeling, crouching or crawling
• Manual Dexterity (e.g. picking, pinching, typing, or other working that uses fingers)
• Grasping (e.g., use of hand of apply pressure)
• Feeling (e.g. perceiving an objects size, shape, texture etc.)
• Climbing (e.g. ascending/descending ladders, stair, scaffolding, ramps, pole etc. using feet and legs or hands/arms to climb)
• Hearing
• Talking
• Capacity to think, concentrate and focus over long periods of time
• Ability to read/write complex documents in the English language
• Capacity to reason and make sound decisions
• Capacity to express thoughts orally
• Ability to regularly perform all job functions at companys office or work site
• Travel required 30% #LI-AM1

Diversity, Inclusion & Equal Employment Opportunity

Day & Zimmermann is committed to maintaining an inclusive workforce, where employees are hired, retained, compensated and promoted based on their contributions to our Company. Our collective strength is rooted in over a century of diverse employees and businesses, commitment to success, and delivery on promises made. Federal and state Equal Employment Opportunity laws prohibit employment discrimination based on race, color, religion, sex, sexual orientation, age, national origin, citizenship status, veteran status and disability status. Day & Zimmermann is committed to providing an equal opportunity work environment in full compliance with these laws. If you are an individual with a disability and you require an accommodation in the application process, please email , and please specify which position you are interested in, including job title and location.

Connect with us:

About Day and Zimmermann

No problem is too challenging or complex for Day & Zimmermann Maintenance and Construction (DZMC) because We do what we say! We're here to make life easier for plant owners in the Power, Chemical, and Industrial markets. With our wide-ranging capabilities and long-standing industry experience, we deliver innovative solutions and seamless processes that effectively manage all aspects of the plant life cycle. It's no wonder we're the #1 maintenance services provider in the United States. Come join in on our purpose - We put people to work, we protect American freedoms, and we help our customer's power and improve the world!

Position Description

We're looking for a full-time,Director, Quality Assurance to join ourDay & Zimmermann team.

Provide Quality Assurance management direction and oversight for QA programs including Nuclear, DOE, DoD, Solar and ISO programs.Manage all QA procedures and verify proper imlementation and address all related issues. Assures through oversight that Quality Assurance activities for the company and venders are defined, planned, implemented and documented in accordance with client, company and industry standards.

As the Director Quality Assurance, here's the work you'll do:

• Provide direction and oversight of QA Programs - DOE, DoD, Nuclear, Solar, ISO-9001
• Assures through oversight that Quality Assurance activities for the company and suppliers are defined, planned, implemented and documented in accordance with client, company and industry standards
• Establish and coordinates all audit activities for all business units and project organizations. This includes all vendor and supplier audits and maintain the corporate's Approved Supplier Lists.
• Coordinates activities to ensure that Quality Program budgets, schedules and priorities are met.
• Advises senior quality management and business unit managers of quality related deficiencies, audit findings, regulatory and third party inspection issues.A Provides recommended resolution of the identified quality issues

This role is for you if you have these skills:

• Analytical ability to grasp key factors from detailed specifications
• Effective verbal communication and report writing skills
• Working knowledge of construction industry Codes and Standards - Welding Processes
• Good leadership capabilities to lead quality initiatives to successful completion
• Basic knowledge of applicable software to compile quality process data.
• Familiar with the tools, concepts and methodologies of quality management

And if you have these qualifications:

• College degree or equivalent experience
• 15 years Quality related experience
• Lead Auditor, Auditor Certification

In compliance with this states pay transparency laws, the salary range for this role is $124,080 - $186,120. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. (The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements)

We care about our employees, and it shows. Our staff receive a competitive salary and a comprehensive benefits package which includes medical/Rx, dental and vision coverage; life, AD&D and disability insurance; flexible spending accounts; 100% paid maternity leave for up to 12 weeks, parental leave, family leave, other paid time off; voluntary benefits and discount programs to meet our employeesindividual needs including pet insurance for our furry family members!

To ensure a safe work environment while meeting the physical demands of the job, you must be able to perform the following physical and mental tasks, with or without a reasonable accommodation:

• Visual acuity (e.g., needed to prepare and analyze data, to transcribe documents, to view a computer, to read, to inspect objects, to operate machinery
• Balancing (e.g., maintaining equilibrium when walking, climbing, crouching etc.)
• Stooping (e.g., bending the spine at the waist)
• Walking
• Kneeling, crouching or crawling
• Manual Dexterity (e.g. picking, pinching, typing, or other working that uses fingers)
• Grasping (e.g., use of hand of apply pressure)
• Feeling (e.g. perceiving an objects size, shape, texture etc.)
• Climbing (e.g. ascending/descending ladders, stair, scaffolding, ramps, pole etc. using feet and legs or hands/arms to climb)
• Hearing
• Talking
• Capacity to think, concentrate and focus over long periods of time
• Ability to read/write complex documents in the English language
• Capacity to reason and make sound decisions
• Capacity to express thoughts orally
• Ability to regularly perform all job functions at companys office or work site
• Travel required 30% #LI-AM1

Diversity, Inclusion & Equal Employment Opportunity

Day & Zimmermann is committed to maintaining an inclusive workforce, where employees are hired, retained, compensated and promoted based on their contributions to our Company. Our collective strength is rooted in over a century of diverse employees and businesses, commitment to success, and delivery on promises made. Federal and state Equal Employment Opportunity laws prohibit employment discrimination based on race, color, religion, sex, sexual orientation, age, national origin, citizenship status, veteran status and disability status. Day & Zimmermann is committed to providing an equal opportunity work environment in full compliance with these laws. If you are an individual with a disability and you require an accommodation in the application process, please , and please specify which position you are interested in, including job title and location.