Senior QA Inspector -- Medical Device Metrology & Nonconformance Control

Are you the detail-obsessed inspector who keeps product quality uncompromised?

Do you enjoy turning GD&T into clear pass/fail outcomes? Can you set up a Hexagon CMM, validate calibration on your gages before the first measurement, and document with GDP precision? If this sounds like you, read on.

The mission

Protect patients and customers by ensuring precision-machined and assembled medical device components meet drawings, specifications, and regulatory standards. This in-person role operates under ISO 13485:2016 and FDA 21 CFR 820 (QMSR) and carries responsibility for inspection-based product acceptance and robust nonconformance control.

Reporting to

Head of Quality

What you’ll take ownership of

• All stages of inspection: Incoming, first article (FAI), in-process, and final inspections following approved procedures.
• Verification and release: Dimensional, visual, and functional checks on machined and assembled components; authorize movement only of conforming product and label status as Accepted / Rejected / On Hold.
• Nonconformance rigor: Identify, document, and segregate nonconforming items; initiate NCRs; participate in MRB; aid root cause analysis and CAPA to prevent recurrence.
• Metrology discipline: Confirm calibration status before use; operate and care for precision tools (calipers, micrometers, height/bore/thread/plug/ring gauges, dial indicators, surface roughness testers) and perform routine functional verification; manage identification, traceability, storage, and handling; coordinate internal/external calibration.
• Documentation excellence: Capture accurate, complete records per GDP; support batch record review and release documentation.
• Quality system contributions: Support FAIs, MSA studies, and process validations; maintain product identification and traceability; champion continuous improvement in inspection and quality processes.
• Operational standards: Maintain a clean, organized, 5S-compliant area; follow safety, GMP, and regulatory rules; promptly report abnormal conditions and risks.
• Adaptability: Jump in on other duties to meet manufacturing and operational priorities.

Must-have capabilities

• Technical diploma or equivalent in Engineering, Manufacturing, or related field.
• 2+ years of inspection experience in machining/precision or regulated manufacturing (medical device preferred).
• Proficiency reading prints with basic GD strong measurement fundamentals.
• Confidence with precision instruments and CMM-based dimensional inspection (Hexagon preferred).
• Consistent accuracy measuring machined components.
• Knowledge of ISO 13485:2016 and FDA 21 CFR 820 (QMSR) preferred.
• Detail orientation with rigorous GDP.
• Ability to work independently and collaborate across teams in a fast-paced shop.
• Fluency with Microsoft Word, Excel, Outlook; solid electronic record entry; ERP/MES familiarity preferred.

When and where you’ll work

• Schedule: 7:00 AM – 3:30 PM; overtime may include extended weekdays and occasional weekends as business needs dictate.
• On-site across manufacturing and controlled inspection environments with typical machining shop noise and pace.
• PPE required in designated areas: safety shoes, safety glasses, gloves, masks, face shields, and protective garments as needed.

Physical realities

• Regular standing, walking, and precision hand use; effective verbal and written communication.
• Occasional lifting up to 25 lbs.
• Prolonged visual inspection and computer documentation; close-range visual acuity is essential.

Getting here

• Reliable transportation required; our facility is in an industrial area with limited public transit.

Your edge

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

Tools you’ll master

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