Senior Medical Device Metrology and Inspection Specialist

Job Description

Job Description

Senior Medical Device Metrology and Inspection Specialist

Day in the Life

At 7:00 AM you’re on the floor, confirming calibration status and setting up gauges. Your morning begins with incoming inspections—verifying dimensions, finishes, and function on precision-machined and assembled medical device parts. As first articles (FAI) arrive, you methodically confirm conformance to drawings, specifications, and applicable procedures, anchoring acceptance decisions to ISO 13485:2016 and FDA 21 CFR 820 (QMSR) requirements. Throughout the day, you alternate between in-process checks that keep production running smoothly and final inspections that determine product release.

When something’s off, you don’t just flag it—you document the nonconformance, segregate the material, and open an NCR. You collaborate on MRB dispositions, support root cause exploration, and contribute to CAPA activities to prevent recurrence. You keep product identification and status crystal clear—Accepted, Rejected, or On Hold—so nothing moves forward unless it should.

Precision tools are your craft: calipers, micrometers, height and bore gauges, thread/plug/ring gauges, dial indicators, and surface roughness testers. You’re comfortable at the CMM—ideally on a Hexagon system—executing dimensional programs to validate critical features. Between runs, you care for gauges, verify functional performance, and help coordinate calibrations with internal and external providers. Your workspace reflects 5S discipline and contamination control, and your records exemplify GDP: accurate, complete, and traceable.

• Inspection & Verification: Perform incoming, FAI, in-process, and final inspections against engineering drawings and specifications; ensure only conforming parts advance or ship.
• Product Release: Support disposition decisions; deliver clear, timely feedback to production and engineering; maintain visible product status.
• Nonconformance Control: Identify, document, segregate, and control nonconforming product; initiate NCRs; participate in MRB; support root cause and CAPA efforts.
• Metrology & Gage Management: Confirm calibration before use; operate and maintain precision tools and CMM equipment; ensure identification, traceability, storage, and handling; support calibration coordination and routine care/verification.
• Documentation & Data Integrity: Record results per Good Documentation Practices; maintain complete, traceable inspection records; assist with batch record review and release paperwork.
• Quality System Engagement: Contribute to FAI packages, MSA activities, process validations, and continuous improvement of inspection methods and processes; maintain product identification and traceability.
• Workplace Compliance & 5S: Keep inspection areas organized and compliant; follow safety, GMP, and regulatory expectations; promptly report abnormalities or risks.
• Other Duties: Adapt to evolving manufacturing, quality, and operational priorities.

• Reports to: Head of Quality
• Location: In-person, on site
• Work Schedule: 7:00 AM – 3:30 PM; overtime may include extended weekdays and occasional weekends based on business needs

Work occurs in manufacturing and controlled inspection spaces with typical machining noise and fast-paced activity. PPE is required in designated areas and may include safety shoes, safety glasses, gloves, masks, face shields, and protective garments. The role requires standing and walking, hands-on precision measurement, and effective communication. You may occasionally lift up to 25 lbs. Extended visual inspection and computer-based documentation are routine; close visual acuity is essential.

Reliable transportation is required; the facility is in an industrial area with limited access to public transit.

• Technical diploma or equivalent in Engineering, Manufacturing, or related discipline
• 2+ years of inspection experience in machining, precision manufacturing, or other regulated manufacturing (medical device preferred)
• Fluency in reading engineering drawings with basic GD&T
• Proficiency with calipers, micrometers, height/bore gauges, thread/plug/ring gauges, dial indicators, and surface roughness testers
• Dimensional inspection using CMM equipment (Hexagon preferred)
• Consistent, accurate measurement of machined components
• Familiarity with ISO 13485:2016 and FDA 21 CFR 820 (QMSR) preferred
• Strong attention to detail with Good Documentation Practices (GDP)
• Comfort working independently and collaboratively in a fast-paced manufacturing setting
• Computer literacy in Microsoft Word, Excel, Outlook
• Accurate electronic data entry and record-keeping; experience with ERP/MES or similar systems preferred

• Quality Inspection and Control
• FDA Regulations and 21 CFR 820 (QMSR)
• Precision Measurement & Inspection
• Quality Control Data Analysis
• Blueprint Reading
• ISO 13485:2016

• Coordinate Measuring Machine (CMM) — Hexagon preferred
• Measurement gauges
• Calipers and micrometers