Lead Precision Quality Inspector, ISO 13485 (CMM/FAI)

Impact first

Help ensure every precision-machined and assembled medical device component we ship conforms to drawings, specifications, and regulatory requirements. In this in-person role, you own inspection-based acceptance decisions and strengthen our nonconformance control across the product lifecycle—aligned with ISO 13485:2016 and FDA 21 CFR 820 (QMSR).

Reporting line

Reports to Head of Quality

Core responsibilities

• Incoming through final inspection: Conduct receiving, FAI, in-process, and final inspections per controlled procedures.
• Verification of conformance: Perform dimensional, visual, and functional checks on machined and assembled components; release only conforming product.
• Disposition & status control: Document results, communicate clearly, and maintain Accepted / Rejected / On Hold identification.
• Nonconformance management: Raise NCRs, segregate suspect material, support MRB, and contribute to root cause and CAPA.
• Metrology stewardship: Confirm calibration status, operate and maintain precision tools and gauges, ensure proper identification/traceability/storage/handling, coordinate internal/external calibration, and conduct routine functional verification.
• Documentation & GDP: Capture accurate, complete records; support batch record review and product release documentation.
• Quality system enablement: Participate in FAI studies, MSA, and process validation; maintain product identification and traceability; drive continuous improvement of inspection methods and quality processes.
• Workplace compliance: Uphold 5S, contamination control, safety, GMP, and regulatory requirements; report abnormal conditions and risks promptly.
• Additional support: Perform other tasks necessary to meet manufacturing and operational needs.

Minimum qualifications

• 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 engineering drawings with basic GD&T.
• Skilled with calipers, micrometers, height/plug/ring/thread/bore gauges, dial indicators, and surface roughness testers.
• Experience performing dimensional inspection using a CMM (Hexagon preferred).
• Demonstrated measurement accuracy and repeatability on machined components.
• Familiarity with ISO 13485:2016 and FDA 21 CFR 820 (QMSR) preferred.
• Strong attention to detail; strict adherence to GDP.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficient with Microsoft Word, Excel, Outlook; experience with ERP/MES data entry and electronic records preferred.

Schedule & conditions

• Regular hours: 7:00 AM – 3:30 PM; overtime may include extended weekdays and occasional weekends based on production demands.
• On-site role within manufacturing and controlled inspection areas; exposure to typical machining shop noise and pace.
• PPE required in designated areas: safety shoes, safety glasses, gloves, masks, face shields, protective clothing as needed.

Physical demands

• Frequent standing and walking; precise hand use for measurement; effective communication.
• Occasional lifting up to 25 lbs.
• Extended periods of visual inspection and computer-based documentation; close-range visual acuity required.

Logistics

• Reliable transportation to an industrial site with limited public transit access.

Tools and technologies

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

Strengths that set you up for success

• 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