Quality Control Manager

About the Company

A well-established medical device contract manufacturer operating in a regulated environment is seeking an experienced Quality Control Manager to lead their QC function. This is a full-time onsite position based in Gardner MA no hybrid or remote options are available.

Position Overview

The Quality Control Manager is responsible for leading and maintaining all quality control activities within a predominantly Class II medical device contract manufacturing environment. This role ensures compliance with FDA regulations ISO 13485 and customer-specific requirements across the full spectrum of QC operations including metrology and calibration incoming inspection in-process and final product acceptance DHR review nonconforming material management and team leadership. The ideal candidate brings deep technical knowledge of medical device inspection methodologies and metrology combined with proven supervisory experience and the ability to collaborate cross-functionally with Manufacturing Engineering Supply Chain Regulatory Affairs and Quality Assurance.

Key Responsibilities

Quality Control Operations

• Manage daily QC operations to ensure timely inspection testing review and release of materials and finished devices
• Establish priorities and allocate resources to meet production schedules while maintaining full compliance
• Develop implement and maintain QC procedures work instructions inspection methods and acceptance criteria
• Ensure all QC activities are performed per approved procedures and appropriately documented

Incoming Inspection

• Oversee receipt inspection programs for components raw materials labels packaging and outsourced services
• Review and disposition incoming inspection results and supporting supplier documentation
• Support supplier quality activities performance monitoring and corrective action processes
• Ensure risk-based inspection methodologies are effectively implemented

Final Product Testing & Release

• Manage final inspection and product acceptance activities
• Ensure all device testing is performed per validated methods and approved specifications
• Review quality records supporting final product acceptance
• Authorize or oversee final release of finished medical devices prior to shipment

Device History Record (DHR) Review

• Perform or oversee comprehensive DHR reviews for completeness accuracy and traceability
• Ensure all required documentation signatures and approvals are in place before product release
• Identify documentation deficiencies and coordinate corrections with relevant departments

Calibration & Metrology

• Administer and continuously improve the calibration program for all inspection measuring and test equipment
• Ensure calibration activities are performed within established intervals and traceable to recognized standards
• Investigate and assess the impact of out-of-tolerance equipment findings
• Coordinate external calibration vendors and manage equipment qualification and maintenance
• Apply metrology principles to measurement system development and quality control processes
• Maintain familiarity with Gage R&R and measurement system analysis methodologies

Nonconforming Product Management

• Identify document segregate and control nonconforming materials and products
• Participate in MRB activities and support CAPA complaint and audit-related investigations
• Issue SCARs and manage return-to-vendor processes as appropriate

Team Leadership

• Lead coach mentor and develop a team of 45 Quality Control Inspectors and Technicians
• Conduct training qualification and competency assessments
• Establish departmental goals performance metrics and support employee development
• Promote a culture of quality compliance accountability and continuous improvement

Quality Systems & Continuous Improvement

• Support internal customer and supplier audits as well as regulatory inspections
• Participate in CAPA investigations and effectiveness verification
• Assist with process validation equipment qualification and manufacturing improvement initiatives
• Analyze quality performance metrics and identify trends and opportunities for improvement
• Participate in Management Review and QMS improvement activities

Qualifications

Required:

• Bachelors 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
• 23 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

Preferred:

• 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

Physical Requirements

• 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

Equal Opportunity Statement

This employer is committed to building a diverse and inclusive workplace. All qualified applicants will be considered without regard to race color religion sex sexual orientation gender identity national origin age disability veteran status or any other characteristic protected under applicable federal state or local law.