Associate Director, Metrologist and Compliance Lead, Medical Devices and Combination Products

Job Description:

Are you passionate about ensuring measurement accuracy, laboratory compliance, and the integrity of test data used to support the development and commercialization of innovative medical devices and combination products? Join our Device Development & Technology (DD&T) organization as a Metrologist & Compliance Lead supporting our laboratories including an ISO 13485-certified Design Verification Laboratory. This role is responsible for maintaining laboratory measurement systems, calibration programs, equipment qualification, and computer system validation activities, and quality system compliance to ensure reliable, traceable, and regulatory-compliant test results.

The Metrologist & Compliance Lead serves as a technical leader for laboratory metrology practices and quality compliance activities, supporting development activities for pipeline products from feasibility to commercialization including but not limited to design verification, test method development and validation, aging/stability studies, process validation testing, incoming inspection, and release testing activities. This position works closely with DD&T functions and Quality Assurance, suppliers, and external service providers to ensure laboratory operations meet applicable regulatory requirements and industry standards.

• Lead and maintain the DD&T Laboratories calibration and metrology program to ensure measurement traceability to national and international standards.
• Develop, implement and continuously improve calibration procedures, equipment qualification protocols, and maintenance programs for all laboratory equipment and measurement systems.
• Manage calibration status, scheduling and documentation, evaluate measurement uncertainty, and ensure appropriate metrological control of critical test equipment.
• Support installation qualification (IQ), operational qualification (OQ) and computer system validation for lab equipment, and investigate failures and measurement discrepancies.
• Serve as the laboratory compliance representative for DD&T laboratories, ensuring quality system requirements and laboratory procedures are met and maintaining audit readiness for internal, external and regulatory inspections.
• Partner with Quality Assurance to manage deviations, nonconformances, CAPAs and change controls affecting laboratory operations, and keep documentation in line with Good Documentation Practices and data integrity requirements.
• Collaborate with Design Verification Leads to ensure test equipment and measurement methods are qualified and compliant, forecast testing resources, and support validation and transfer of test methods within design verification programs.
• Lead procurement, qualification and lifecycle management of laboratory instrumentation, monitor environmental controls and coordinate external calibration vendors and service providers.
• Maintain laboratory asset inventories, identify capability gaps, and recommend new technologies, equipment and measurement capabilities.
• Stay current with regulations, guidance documents and industry standards, support audits and inspections and participate in risk management activities related to laboratory operations.
• Drive implementation of metrology and laboratory compliance best practices across the DD&T organization.

• B.S. in Mechanical Engineering, Biomedical Engineering, Quality Engineering, Metrology, Physics, or a related scientific discipline with 8+ years of relevant industry experience, or M.S. in a related discipline with 5+ years of relevant industry experience.
• Experience supporting ISO 13485‑certified medical device or combination product development laboratories.
• Demonstrated expertise in metrology principles, calibration systems, measurement uncertainty and traceability requirements.
• Experience with equipment qualification (IQ/OQ) and computer system validation activities.
• Strong knowledge of design controls, risk management and medical device quality management system requirements.
• Experience managing deviations, nonconformances, investigations, CAPAs and change controls.
• Skilled in laboratory documentation practices and electronic…