QC Manager

Role Summary

Lead the daily operations of the Quality Control department, ensuring all medical devices are manufactured, tested, and released in strict compliance with ISO 13485, FDA 21 CFR Part 820, and internal specifications. You will manage the inspection team, oversee product testing, and drive continuous improvement in manufacturing quality.

Key Responsibilities

• Team Leadership: Supervise, train, and mentor a team of QC Inspectors and Technicians across incoming, in-process, and final inspection.
• Inspection Oversight: Manage the execution of inspection plans, ensuring accurate verification of dimensions, functionality, and cosmetic standards.
• Non-Conformance Management: Lead the investigation of Non-Conforming Materials (NCRs); facilitate Root Cause Analysis (RCA) and coordinate material disposition (Scrap, Rework, Return).
• Equipment & Calibration: Oversee the calibration program for all monitoring and measuring equipment; ensure validation of QC test methods.
• Documentation: specific Ensure the accuracy and integrity of Device History Records (DHR) prior to product release.
• Data Analysis: Monitor quality metrics (yields, defect rates) using Statistical Process Control (SPC) to identify trends and trigger Corrective and Preventive Actions (CAPA).
• Audit Support: Serve as a Subject Matter Expert (SME) for QC processes during ISO/FDA audits and internal quality audits.

Qualifications

• Education: Bachelor’s degree in Engineering (Biomedical, Mechanical, Industrial), Pharmacy or a relevant Life Science field.
• Experience: 4+ years of quality experience in Medical Device/Pharmaceutical manufacturing (Class II/III preferred), with at least 2 years in a supervisory role.
• Regulatory Knowledge: Expert understanding of ISO 13485, GMP and FDA 21 CFR Part 820/EUMDR.
• Technical Skills: Proficiency in reading engineering drawings (GD&T), using precision measurement tools (CMM, calipers, micrometers), and standard sampling plans (ANSI/ASQ Z1.4).

Preferred Skills

• ASQ Certified Quality Engineer (CQE) or Manager of Quality/Organizational Excellence (CMQ/OE).
• Experience with eQMS software (e.g., MasterControl, Greenlight Guru, Arena).
• Lean Six Sigma Green Belt or higher.

Job Types: Full-time, Part-time

Expected hours: 20 per week

Work Location: In person