Associate Director, Metrologist and Compliance Lead, Medical Devices and Combination Products
Core
Lead metrology and compliance programs for medical device and combination product development laboratories, ensuring measurement accuracy, equipment qualification, and regulatory adherence.
Role type
Associate Director, Metrologist and Compliance Lead
Builds
Reliable, traceable, and regulatory-compliant test results for pipeline products from feasibility to commercialization
Domain
Medical Devices and Combination Products / Laboratory Metrology and Quality Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
metrology principles, calibration systems, measurement uncertainty, traceability, equipment qualification (IQ/OQ), computer system validation, design controls, risk management, deviation/CAPA/change control management, laboratory documentation practices
Preferred skills
design verification, test method validation, CMM/optical measurement/laser metrology/dimensional inspection, XRCT imaging/non-destructive inspection/digital microscopy, compression/tensile testing, statistical analysis/MSA/Gage R&R, LIMS/electronic document management, supplier quality management, notified body/FDA/regulatory inspection support, root cause investigations, training and mentoring
Technologies
CMM, optical measurement systems, Keyence systems, laser metrology, dimensional inspection technologies, XRCT imaging, non-destructive inspection, digital microscopy, compression and tensile testing systems, LIMS
Responsibilities
Lead and maintain calibration and metrology programs ensuring 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; Serve as the laboratory compliance representative 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; Lead investigations related to failures, out-of-tolerance conditions, and measurement discrepancies; Collaborate with Design Verification Leads to ensure testing equipment and measurement methods are appropriate, qualified, and compliant; Lead procurement, qualification, and lifecycle management of laboratory instrumentation and metrology equipment; Stay current with applicable regulations, guidance documents, and industry standards
Seniority
Associate Director, technical leader
