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

Job description

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. The role is responsible for establishing and maintaining laboratory systems that support accurate measurements, equipment reliability, data integrity, and audit readiness. Success requires deep understanding of measurement science, calibration systems, design controls, risk management, laboratory quality systems, and applicable medical device and combination product regulations. Principal Responsibilities Metrology & Calibration 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. Manage calibration status, scheduling, and documentation for all laboratory equipment and measurement systems. Evaluate measurement uncertainty and ensure appropriate metrological control of critical test equipment. Support installation qualification (IQ), operational qualification (OQ), and computer system validation activities for laboratory equipment. Lead investigations related to failures, out-of-tolerance conditions, and measurement discrepancies. Ensure appropriate control of metrology records, calibration certificates, and traceability documentation. Laboratory Compliance & Quality Systems Serve as the laboratory compliance representative for DD&T laboratories including an ISO 13485 certified lab ensuring quality system requirements and applicable laboratory procedures are met. Maintain inspection and audit readiness for internal/external audits, supplier audits, notified body inspections, and regulatory inspections. Support implementation and maintenance of laboratory procedures, work instructions, forms, and quality records. Partner with Quality Assurance to manage deviations, nonconformances, CAPAs, and change controls impacting laboratory operations. Ensure compliance with Good Documentation Practices (GDP), electronic data management systems, and data integrity requirements. Perform periodic reviews of laboratory processes and identify opportunities for continuous improvement. Design Verification Support Collaborate with Design Verification Leads to ensure testing equipment and measurement methods are appropriate, qualified, and compliant. Partner closely with Design Verification Leads to forecast testing resource needs, prioritize laboratory activities, and ensure qualified equipment, metrology assets, and laboratory capacity are available to support design verification execution and critical program milestones and timelines. Support development, validation, and transfer of test methods used within design verification programs. Provide technical guidance regarding measurement systems, data analysis, and test method robustness. Equipment & Laboratory Management Lead procurement, qualification, and lifecycle management of laboratory instrumentation and metrology equipment. Monitor laboratory environmental controls and ensure compliance with environmental requirements where applicable. Coordinate external calibration vendors and service providers, including approval of records. Maintain laboratory asset inventories and equipment lifecycle records. Identify laboratory capability gaps and develop recommendations for new technologies, equipment, and measurement capabilities. Regulatory & Standards Support Stay current with applicable regulations, guidance documents, and industry standards. Support and participate in internal, external, and regulatory audits and inspections, ensuring laboratory audit readiness through maintenance of compliant documentation, equipment records, calibration traceability, training records, and quality system requirements.Participate in risk management activities related to testing, measurement systems, and laboratory operations, as needed. Drive implementation of best practices in metrology and laboratory compliance across the DD&T organization. Qualifications Requirements: 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 quality systems. Proven ability to work across multidisciplinary technical teams. Strong organizational, communication, project management, and problem-solving skills. Preferred experiences include: Medical device or combination product development. Design verification and test method validation activities. Coordinate Measuring Machines (CMM), optical measurement systems, Keyence systems, laser metrology, and dimensional inspection technologies. XRCT imaging, non-destructive inspection, digital microscopy, and advanced measurement systems. Compression and tensile testing systems (Instron, Zwick, Texture Analyzer). Statistical analysis, measurement system analysis (MSA), and Gage R&R studies. Laboratory Information Management Systems (LIMS) and electronic document management systems. Supplier quality management and external laboratory oversight. Experience supporting notified body, FDA, and international regulatory inspections. Root cause investigations involving measurement systems and laboratory equipment. Training and mentoring laboratory personnel on metrology and compliance requirements. Fluency with industry-related guidance & standards: ISO 13485 – Medical Device Quality Management Systems ISO 14971 – Risk Management for Medical Devices ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories 21 CFR Part 820 (Quality Management System Regulation) 21 CFR Part 4 (Combination Products) 21 CFR Parts 210/211 EU Medical Device Regulation (EU MDR) ISO 11608 ISO 11040 ISO 80369 ISO 10993 ASTM F1980 ASTM D4169 ASTM F1886 ISTA 3A/3B Data Integrity and Good Documentation Practices requirements Device design controls and design verification requirements. Required Skills: Calibration Management Software, Data