Quality Compliance Manager
Flex, Buffalo Grove, IL, United States
Overview
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don’t meet every bullet point, we encourage you to apply and join us to create the extraordinary.
The
Quality Compliance Manager
will be based in
Buffalo Grove, IL , reporting to
Sr. Quality Manager . The
Quality Compliance Manager
will be responsible for leading and maintaining a compliant analytical laboratory that supports medical device manufacturing, product release, validation, and laboratory investigations. This role ensures laboratory operations meet FDA Quality Management System Regulation (21 CFR Part 820), ISO 13485:2016, and applicable international regulatory requirements. The manager provides technical and people leadership, ensures data integrity, and drives continuous improvement while always maintaining inspection readiness.
What a typical day looks like:
Responsibilities
Laboratory Leadership & Operations: Lead day‑to‑day analytical laboratory operations supporting incoming inspection, in‑process controls, final product release, validation, and complaint investigations
Ensure analytical testing is accurate, timely, and aligned with product and regulatory requirements
Review and approve analytical test results, reports, and data packages prior to product disposition
Establish priorities and resource allocation to support production and quality needs
Regulatory Compliance & Quality Systems: Ensure laboratory compliance with FDA QMSR (21 CFR 820), ISO 13485, and applicable ISO testing standards
Author, review, approve, and maintain laboratory SOPs, work instructions, test methods, and validation protocols
Maintain inspection readiness and support FDA, notified body, customer, and internal audits
Lead or support laboratory investigations including OOS/OOT, nonconformances, deviations, CAPAs, and change controls
Ensure ALCOA+ data integrity principles are implemented and sustained within the laboratory
Analytical Methods & Equipment: Oversee development, validation, verification, and lifecycle management of analytical methods
Ensure laboratory equipment is properly qualified, calibrated, maintained, and documented
Manage equipment obsolescence, upgrades, and new technology introduction
Evaluate and select external test laboratories when internal testing is not available
People Management & Development: Directly manage laboratory analysts, technicians, and/or supervisors
Ensure personnel training, qualification, and competency assessments are completed and maintained
Mentor staff on technical skills, GMP compliance, documentation, and root cause analysis
Promote a culture of accountability, quality, and continuous improvement
Safety & Environmental Compliance: Ensure laboratory compliance with EHS requirements, chemical hygiene plans, and waste disposal regulations
Promote safe laboratory practices and respond to safety incidents or near misses
Continuous Improvement & Cross‑Functional Support: Drive continuous improvement initiatives to enhance laboratory efficiency, compliance, and cost effectiveness
Partner with Manufacturing, Engineering, Supplier Quality, R&D, and Regulatory Affairs to resolve quality and technical issues
Support process validation, design verification/validation (DV/PV), and technology transfers
Qualifications
Bachelor’s degree in chemistry, Analytical Chemistry, Materials Science, Engineering, or related scientific discipline
Minimum 7+ years of analytical laboratory experience in a regulated medical device or life sciences environment
At least 2 years of people leadership or technical leadership experience
Strong working knowledge of analytical techniques such as HPLC, GC, FTIR, UV‑Vis and wet chemistry
Solid understanding of FDA QSR, ISO 13485, and medical device quality systems
Experience with Laboratory Information Management Systems (LIMS) (preferred)
Six Sigma, Lean, or formal root cause analysis training (preferred)
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We\u2019re happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we\u2019ll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).
#J-18808-Ljbffr
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don’t meet every bullet point, we encourage you to apply and join us to create the extraordinary.
The
Quality Compliance Manager
will be based in
Buffalo Grove, IL , reporting to
Sr. Quality Manager . The
Quality Compliance Manager
will be responsible for leading and maintaining a compliant analytical laboratory that supports medical device manufacturing, product release, validation, and laboratory investigations. This role ensures laboratory operations meet FDA Quality Management System Regulation (21 CFR Part 820), ISO 13485:2016, and applicable international regulatory requirements. The manager provides technical and people leadership, ensures data integrity, and drives continuous improvement while always maintaining inspection readiness.
What a typical day looks like:
Responsibilities
Laboratory Leadership & Operations: Lead day‑to‑day analytical laboratory operations supporting incoming inspection, in‑process controls, final product release, validation, and complaint investigations
Ensure analytical testing is accurate, timely, and aligned with product and regulatory requirements
Review and approve analytical test results, reports, and data packages prior to product disposition
Establish priorities and resource allocation to support production and quality needs
Regulatory Compliance & Quality Systems: Ensure laboratory compliance with FDA QMSR (21 CFR 820), ISO 13485, and applicable ISO testing standards
Author, review, approve, and maintain laboratory SOPs, work instructions, test methods, and validation protocols
Maintain inspection readiness and support FDA, notified body, customer, and internal audits
Lead or support laboratory investigations including OOS/OOT, nonconformances, deviations, CAPAs, and change controls
Ensure ALCOA+ data integrity principles are implemented and sustained within the laboratory
Analytical Methods & Equipment: Oversee development, validation, verification, and lifecycle management of analytical methods
Ensure laboratory equipment is properly qualified, calibrated, maintained, and documented
Manage equipment obsolescence, upgrades, and new technology introduction
Evaluate and select external test laboratories when internal testing is not available
People Management & Development: Directly manage laboratory analysts, technicians, and/or supervisors
Ensure personnel training, qualification, and competency assessments are completed and maintained
Mentor staff on technical skills, GMP compliance, documentation, and root cause analysis
Promote a culture of accountability, quality, and continuous improvement
Safety & Environmental Compliance: Ensure laboratory compliance with EHS requirements, chemical hygiene plans, and waste disposal regulations
Promote safe laboratory practices and respond to safety incidents or near misses
Continuous Improvement & Cross‑Functional Support: Drive continuous improvement initiatives to enhance laboratory efficiency, compliance, and cost effectiveness
Partner with Manufacturing, Engineering, Supplier Quality, R&D, and Regulatory Affairs to resolve quality and technical issues
Support process validation, design verification/validation (DV/PV), and technology transfers
Qualifications
Bachelor’s degree in chemistry, Analytical Chemistry, Materials Science, Engineering, or related scientific discipline
Minimum 7+ years of analytical laboratory experience in a regulated medical device or life sciences environment
At least 2 years of people leadership or technical leadership experience
Strong working knowledge of analytical techniques such as HPLC, GC, FTIR, UV‑Vis and wet chemistry
Solid understanding of FDA QSR, ISO 13485, and medical device quality systems
Experience with Laboratory Information Management Systems (LIMS) (preferred)
Six Sigma, Lean, or formal root cause analysis training (preferred)
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We\u2019re happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we\u2019ll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).
#J-18808-Ljbffr