Quality Compliance Manager

Job Summary

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:

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

The experience we’re looking to add to our team:

• 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)

What you'll receive for the great work you provide:

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

Job Category

Is Sponsorship Available?