Location: Greater Chicago, IL
Company: QFocus Technologies
Domain: Manufacturing (Medical)
The Analytical Laboratory Manager is responsible for leading and maintaining a compliant analytical laboratory that supports medical devices manufacturing, product release, validation and laboratory investigations. This role ensures that laboratory operations meet FDA Quality Management System Regulation (21 CFR Part 820), ISO 13485:2016 and other applicable international regulatory requirements. The manager provides technical and people leadership, ensures data integrity and drives continuous improvement while maintaining inspection readiness at all times.
- Lead day‑to‑day analytical laboratory operations, supporting incoming inspection, in‑process controls, final product release, validation, and complaint investigations
- Ensure accuracy and timeliness of analytical testing and its alignment 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 bodies, customers and internal audits
- Lead or support laboratory investigations including OOS/OOT, non-conformances, deviations, CAPAs and change controls
- Ensure that ALCOA+ data integrity principles are implemented and sustained within the laboratory
- Oversee the development, validation, verification and lifecycle management of analytical methods
- Ensure that 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 that personnel training, qualification and competency assessments are completed and maintained
- Mentor staff on technical skills, GMP compliance, documentation and conducting 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
- Bachelor’s degree in Chemistry, Analytical Chemistry, Materials Science, Engineering or related scientific discipline
- Minimum 5–7 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
- Master’s degree in a scientific or engineering discipline
- Direct experience supporting FDA or notified body inspections
- Experience with Laboratory Information Management Systems (LIMS)
- Training in Six Sigma, Lean or formal root cause analysis
QFocus Technologies LLC is an Equal Employment Opportunity employer.
We are a group of passionate and experienced technology professionals working together with a singular focus to delight our customers by delivering quantifiable value and becoming a natural extension of your team!
ops@QFocustech.com
+1-858-208-3015