Position Summary

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. 

Essential Duties and Responsibilities

Quality Control Operations

• 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.

Incoming, In-Process, and Final Inspection

• 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.

DHR Review and Documentation

• 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.

Calibration and Equipment Management

• 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.

Nonconforming Product and Quality Systems

• 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.

Team Leadership and Continuous Improvement

• 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 

Required Qualifications

• 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 participation, and audits.
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485, with an understanding of ISO 14971 risk management principles.
• Knowledge of metrology, calibration systems, Gage R&R, measurement system analysis, statistical sampling, and inspection techniques.
• Ability to interpret engineering drawings, specifications, and test methods.
• Strong leadership, technical writing, documentation, communication, organization, and problem-solving skills.

Preferred Qualifications

• ASQ Certified Quality Engineer, Quality Auditor, or Quality Technician; ISO 13485 Lead Auditor certification.
• Experience with paper-based and electronic DHRs, ERP, electronic QMS, calibration management systems, and IQ/OQ/PQ validation activities.

Key Performance Indicators

Incoming inspection completion; product-release cycle time; DHR review turnaround; calibration compliance; inspection backlog; nonconforming material trends; CAPA and audit closure effectiveness; and internal and external audit outcomes.

Supervisory Responsibility

Supervises Quality Control Supervisor

 Working Conditions 

This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. PPE required when in controlled environment rooms or cleanrooms.

Physical surroundings 

This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.

Physical Effort 

While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. 

Work Schedule / Travel 

In-person, Mon to Fri in Gardner, MA; occasional travel