Senior Medical Device Metrology & FAI Quality Inspector

Job Description

Job Description

What your day could look like

At 7:00 AM you review the queue: incoming lots for receiving inspection, a first article on a new machined component, and several in-process checks awaiting release. You confirm every gage and instrument you’ll use is in calibration, then move between the inspection room and the manufacturing floor, partnering with production and engineering to keep quality flowing without compromise.

By mid-morning you’ve completed an FAI on a complex part using a Hexagon CMM, verified critical dimensions with micrometers and bore/thread gauges, and documented everything with Good Documentation Practices (GDP). After lunch, you disposition lots based on objective evidence, flag a nonconformance, initiate the NCR, and support MRB with clear data. Before you leave, you tidy and 5S the inspection area, verify product status labels (Accepted / Rejected / On Hold), and update batch records to support product release.

This in-person position safeguards the quality of precision-machined and assembled medical device components in accordance with ISO 13485:2016 and FDA 21 CFR 820 (QMSR). You make inspection-based product acceptance decisions and actively support nonconformance control and continuous improvement.

Head of Quality

• Product inspection & verification: Execute incoming, first article (FAI), in-process, and final inspections per procedures, drawings, and specifications. Confirm dimensional, visual, and functional conformance of machined and assembled parts; release only conforming product to the next step or shipment.
• Product release support: Provide clear, traceable inspection evidence for disposition decisions. Communicate results to production and engineering; maintain accurate status identification (Accepted / Rejected / On Hold).
• Nonconforming product control: Identify, document, segregate, and control nonconforming material. Initiate NCRs, participate in MRB, and support root cause, CAPA, and prevention activities.
• Metrology & gage management: Verify calibration prior to use. Operate and care for precision metrology tools (calipers, micrometers, height/bore/thread/plug/ring gauges, dial indicators, surface roughness testers). Maintain identification, traceability, storage, and handling; coordinate calibrations and perform routine functional checks.
• Documentation & data integrity: Record results accurately following GDP. Ensure complete, traceable inspection records; support batch record review and product release documentation.
• Quality system participation: Support FAI, MSA, and process validation activities. Maintain product identification and traceability throughout inspection. Contribute to continuous improvement of methods and processes.
• Workplace standards: Maintain a clean, organized, 5S-compliant inspection area. Follow safety, GMP, and regulatory requirements; escalate abnormal conditions and quality risks promptly.
• Other duties: Assist as needed to meet manufacturing, quality, and operational objectives.

• Technical diploma or equivalent in Engineering, Manufacturing, or related field.
• 2+ years of inspection experience in machining, precision manufacturing, or regulated manufacturing; medical device preferred.
• Fluent in reading engineering drawings with basic GD&T.
• Hands-on proficiency with precision instruments: calipers, micrometers, height gauges, bore/thread/plug/ring gauges, dial indicators, surface roughness testers.
• Competence performing dimensional inspection on a Coordinate Measuring Machine (Hexagon preferred).
• Demonstrated accuracy and consistency inspecting machined components.
• Familiarity with ISO 13485:2016 and FDA 21 CFR 820 (QMSR) preferred.
• Strong attention to detail and impeccable GDP.
• Collaborative and self-directed in a fast-paced manufacturing setting.
• Comfort with Microsoft Word, Excel, Outlook; ability to enter data and maintain e-records; ERP/MES experience preferred.

• Hours: 7:00 AM – 3:30 PM, with potential overtime on weekdays and occasional weekends based on demand.
• Work setting: On-site across manufacturing and controlled inspection areas; typical shop noise and fast-paced workflows.
• PPE: Safety shoes, safety glasses, gloves, masks, face shields, and protective clothing in designated areas per policy.

• Regular standing, walking, precision hand use, and effective communication.
• Occasional lifting up to 25 lbs.
• Extended visual inspection and computer-based documentation; close-range visual acuity required.
• Reliable transportation to an industrial location with limited public transit.

• Coordinate Measuring Machine (Hexagon)
• Measurement gauges, calipers, micrometers

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