Quality Control Manager / Supervisor (Medical Device Manufacturing)

Job Summary

We are seeking a Quality Control Manager / Supervisor to lead Quality Control activities within a regulated medical device contract manufacturing environment. This position will oversee a team of approximately 4 5 direct reports and be responsible for quality control operations, inspection, calibration, product release, DHR review, nonconforming material controls, and continuous improvement.

The ideal candidate will have strong experience in medical device manufacturing, metrology, calibration systems, and quality control , along with proven supervisory or management experience.

Responsibilities

• Manage daily Quality Control operations, including inspection, testing, review, and release of materials and finished medical devices.
• Establish priorities and allocate resources while maintaining production schedules and quality requirements.
• Develop, implement, and maintain QC procedures, work instructions, inspection methods, and acceptance criteria.
• Oversee incoming inspection of components, raw materials, labels, packaging materials, and outsourced manufacturing services.
• Support supplier quality activities and supplier corrective actions.
• Manage final inspection, product testing, and product acceptance activities.
• Review quality records supporting final product acceptance.
• Authorize or oversee final release of finished medical devices.
• Perform or oversee comprehensive Device History Record (DHR) reviews.
• Ensure manufacturing and inspection records are complete, accurate, and traceable.
• Administer and continuously improve the calibration program for inspection, measuring, and test equipment.
• Coordinate external calibration vendors and service providers.
• Manage qualification, maintenance, and monitoring of QC equipment.
• Identify, document, segregate, and control nonconforming materials and products.
• Participate in MRB activities and support investigations involving nonconformances, complaints, CAPAs, and audits.
• Lead, coach, mentor, and develop Quality Control Inspectors and Technicians.
• Conduct training, qualification, and competency assessments.
• Establish departmental goals and performance metrics.
• Support internal, customer, supplier, and regulatory audits.
• Participate in CAPA investigations and process improvement initiatives.
• Support risk management activities and Quality Management System improvements.
• Analyze quality metrics and identify opportunities for continuous improvement.
• Promote a culture of quality, compliance, accountability, and continuous improvement.

Required Qualifications

• 5+ years of Quality Control, Quality Assurance, or Manufacturing Quality experience within the medical device industry.
• Minimum 2 3 years of leadership or supervisory experience.
• Medical device manufacturing experience required.
• Experience with:
  • Incoming inspection
  • Final product inspection
  • Product release
  • DHR review
  • Calibration management
  • Nonconforming material disposition
  • CAPA participation
  • Internal and external audits
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485 .
• Knowledge of metrology and calibration systems .
• Familiarity with Gage R&R and measurement system analysis.
• Ability to interpret engineering drawings, specifications, and test methods.
• Knowledge of statistical sampling plans and inspection techniques.
• Strong technical writing and documentation skills.
• Excellent organizational, problem-solving, verbal, and written communication skills.
• Ability to lead cross-functional teams and influence decision-making.
• ERP, Electronic QMS, and calibration management system experience preferred.

Education

• Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical discipline required.
• Equivalent combination of education and relevant experience may be considered.

Preferred Qualifications

• ASQ CQE, CQA, or CQT certification.
• ISO 13485 Lead Auditor certification.
• Experience with electronic and paper-based DHR systems.
• Experience with validation activities, including IQ/OQ/PQ.
• Contract manufacturing experience preferred.
• Class II medical device experience or higher preferred.
• Experience managing calibration and preventative maintenance systems.
• Experience with supplier management, SCARs, return-to-vendor processes, and final batch release.
• Ability to read engineering drawings and understand dimensions.