Quality Control Manager

Description

The Quality Control Manager leads Quality Control activities in a regulated, predominantly Class II medical device contract manufacturing environment. The position ensures compliance with FDA 21 CFR Part 820, ISO 13485, customer requirements, and internal quality standards. This role oversees inspection and product acceptance, Device History Record (DHR) review, product release, calibration, nonconforming material controls, QC personnel, and continuous improvement.

• Manage daily inspection, testing, documentation review, and release of materials and finished devices.
• Prioritize work and allocate resources to support production schedules while maintaining quality requirements.
• Develop and maintain QC procedures, work instructions, inspection methods, and acceptance criteria.

• Oversee inspection of components, raw materials, labels, packaging, outsourced services, and finished products.
• Confirm supplier certificates, inspection reports, and supporting records meet specified requirements.
• Ensure product testing follows approved specifications and validated methods; assess conformity to design, regulatory, and customer requirements.
• Authorize or oversee final product release before shipment and support supplier quality activities as needed.

• Oversee DHR reviews for completeness, accuracy, traceability, signatures, approvals, and supporting evidence before release.
• Coordinate correction of documentation deficiencies and maintain applicable record-retention requirements.
• Ensure adherence to Good Documentation Practices, data integrity, and record accuracy.

• Administer the calibration program for inspection, measuring, and test equipment, including status identification and record maintenance.
• Ensure calibration is completed on schedule and traceable to recognized standards.
• Investigate out-of-tolerance equipment, assess product impact, and coordinate external calibration providers.
• Oversee qualification, maintenance, and monitoring of QC equipment.

• Identify, document, segregate, control, and support disposition of nonconforming materials and products.
• Participate in Material Review Board activities and investigations involving non-conformances, complaints, CAPAs, and audit findings.
• Support internal, customer, supplier, and regulatory audits; process validation; equipment qualification; ISO 14971 risk management;
  Management Review; and QMS improvements.

• Lead, train, coach, and develop QC Inspectors, Technicians, and supervisory personnel; assess qualifications and competency.
• Establish departmental goals and metrics and support performance management and employee development.
• Analyze inspection and quality trends and implement improvements that strengthen quality, throughput, and compliance.
• Work cross-functionally with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and Quality Assurance

• Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical discipline; an equivalent combination of education and relevant experience may be considered.
• At least 5 years of Quality Control, Quality Assurance, or Manufacturing Quality experience in the medical device industry.
• At least 2-3 years of leadership or supervisory experience.
• Experience in medical device manufacturing; contract manufacturing experience preferred.
• Experience with incoming and final inspection, product release, DHR review, calibration management, nonconforming material disposition, CAPA…