Quality Compliance Manager

Flex•Buffalo Grove, IL

4d•Onsite

About The Position

The Quality Compliance Manager will be based in Buffalo Grove, IL, reporting to the Sr. Quality Manager. This role is responsible for leading and maintaining a compliant analytical laboratory that supports medical device manufacturing, product release, validation, and laboratory investigations. The position 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.

Requirements

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.

Nice To Haves

Experience with Laboratory Information Management Systems (LIMS).
Six Sigma, Lean, or formal root cause analysis training.

Responsibilities

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.
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.
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.
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.
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.
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.