Quality Control Manager
On-siteGardner, Massachusetts, United States
Job Summary
Manage daily QC operations to ensure timely inspection, testing, review, and release of materials and finished devices in a Class II medical device contract manufacturing environment. Oversee incoming inspection programs for components and raw materials, administer the calibration program for all measuring equipment, and perform comprehensive Device History Record reviews for completeness and traceability. Lead a team of four to five inspectors, conduct training and competency assessments, and coordinate with Manufacturing, Engineering, and Regulatory Affairs on CAPA investigations and audits. Authorize final product release and manage nonconforming material disposition while maintaining compliance with FDA 21 CFR Part 820 and ISO 13485 standards.
Required Qualifications
- Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical discipline (equivalent experience considered)
- 5+ years of QC, QA, or manufacturing quality experience in the medical device industry
- 2–3+ years of supervisory or leadership experience with direct reports
- Demonstrated experience in metrology and calibration management — this is a critical requirement for the role
- Hands-on experience with incoming inspection, final product release, DHR review, nonconforming material disposition, CAPA participation, and internal/external audits
- Class II medical device experience or higher required
- Strong knowledge of FDA 21 CFR Part 820 and ISO 13485
- Ability to read and interpret engineering drawings, dimensions, and specifications
- Knowledge of statistical sampling plans, inspection techniques, and risk management principles (ISO 14971)
- Strong technical writing, documentation, and communication skills
- Experience using ERP, electronic QMS, and calibration management systems
- Ability to work in manufacturing and cleanroom environments
- Ability to perform visual inspections
- Occasional lifting up to 25 lbs
- Ability to stand or sit for extended periods as needed
Desired Qualifications
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Certified Quality Technician (CQT)
- ISO 13485 Lead Auditor certification
- Experience with electronic and paper-based DHR systems
- Background in IQ/OQ/PQ validation activities
- Contract manufacturing environment experience
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