Associate Director, Metrologist and Compliance Lead, Medical Devices and Combination Products
$142,400–$224,100 year
On-siteRahway, New Jersey, United States
EXPIREDRahway, New Jersey, United StatesOn-siteFull Time$142,400–$224,100 yearSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
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 while managing calibration status, scheduling, and documentation for all laboratory equipment. Serve as the laboratory compliance representative for ISO 13485-certified facilities, ensuring quality system requirements are met and maintaining inspection and audit readiness for internal, external, supplier, and regulatory inspections. Partner with Design Verification Leads to forecast testing resource needs, prioritize laboratory activities, and support the development and validation of test methods used in design verification programs.
Required Qualifications
- B.S. in Mechanical Engineering, Biomedical Engineering, Quality Engineering, Metrology, Physics, or a related scientific discipline with 8+ years of relevant industry experience
- 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
- Calibration Management Software
- Data Analysis
- Design Controls
- Design Engineering
- Design Thinking
- Design Verification
- Electronic Document Management System (EDMS)
- Laboratory Information Management System (LIMS)
- Manufacturing Methodologies
- Measurement Systems Analysis (MSA)
- Medical Device Quality Systems
- Medical Devices Design
- Medical Product Development
- Product Design
- Product Development Design
- Risk Management
- Statistical Analysis
- Fluency with industry-related guidance & standards: ISO 13485 – Medical Device Quality Management Systems
- Fluency with industry-related guidance & standards: ISO 14971 – Risk Management for Medical Devices
- Fluency with industry-related guidance & standards: ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories
- Fluency with industry-related guidance & standards: 21 CFR Part 820 (Quality Management System Regulation)
- Fluency with industry-related guidance & standards: 21 CFR Part 4 (Combination Products)
- Fluency with industry-related guidance & standards: 21 CFR Parts 210/211
- Fluency with industry-related guidance & standards: EU Medical Device Regulation (EU MDR)
- Fluency with industry-related guidance & standards: ISO 11608
- Fluency with industry-related guidance & standards: ISO 11040
- Fluency with industry-related guidance & standards: ISO 80369
- Fluency with industry-related guidance & standards: ISO 10993
- Fluency with industry-related guidance & standards: ASTM F1980
- Fluency with industry-related guidance & standards: ASTM D4169
- Fluency with industry-related guidance & standards: ASTM F1886
- Fluency with industry-related guidance & standards: ISTA 3A/3B
- Fluency with industry-related guidance & standards: Data Integrity and Good Documentation Practices requirements
- Fluency with industry-related guidance & standards: Device design controls and design verification requirements
Desired Qualifications
- 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)
- 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
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