Senior Quality Inspector Advanced Manufacturing
Listed on 2026-10-05
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Production QC/QA
OXNC DIRECT HIRE Position Summary
Responsible for performing incoming, first article (FAI), in-process, and final inspection activities on precision machined and assembled medical device components in compliance with ISO 13485:2016 and FDA 21 CFR 820 (QMSR). Ensures products meet engineering drawings, specifications, and regulatory requirements prior to release. This role has responsibility for inspection-based product acceptance decisions and support of nonconformance control activities.
Reporting RelationshipReports to Head of Quality
Location:
In-person
Product Inspection & Verification Perform incoming, first article (FAI), in-process, and final inspection according to procedures, drawings, and specifications. Verify dimensional, visual, and functional conformance of machined and assembled components. Ensure only conforming product is released to the next process or shipment.
Product Release Support Support product disposition decisions based on inspection results and applicable procedures. Communicate inspection results clearly to production and engineering personnel. Ensure product status (Accepted / Rejected / On Hold) is properly identified and controlled.
Nonconforming Product Control Identify, document, and segregate nonconforming materials or products in accordance with procedures. Initiate Nonconformance Reports (NCR) and support Material Review Board (MRB) disposition activities. Support root cause investigation and Corrective and Preventive Action (CAPA) activities as required. Ensure nonconforming product is effectively controlled to prevent unintended use, assembly, or shipment.
Measurement Equipment & Gage Management Verify calibration status prior to use of inspection equipment. Operate and maintain precision inspection tools and gauges. Ensure proper identification, traceability, storage, and handling of all inspection equipment. Support calibration coordination activities with internal or external calibration providers. Perform routine care, cleaning, and functional verification of inspection equipment.
Documentation & Data Integrity Record inspection results accurately in compliance with Good Documentation Practices (GDP). Ensure traceability and completeness of all inspection records. Support batch record review and product release documentation as required.
Quality System Support Support First Article Inspection (FAI), Measurement System Analysis (MSA), and process validation activities as required. Maintain product identification and traceability throughout inspection activities. Support continuous improvement of inspection methods and quality processes.
Workplace Compliance & 5SMaintain cleanliness and organization of inspection area in compliance with 5S and contamination control requirements. Follow safety, GMP, and regulatory requirements at all times. Report abnormal conditions, deviations, or potential quality risks in a timely manner.
Other Duties Perform other duties as assigned to support manufacturing, quality, and operational requirements.
- Technical diploma or equivalent in Engineering, Manufacturing, or related field.
- 2+ years of inspection experience in machining, precision manufacturing, or regulated manufacturing environment (medical device preferred).
- Ability to read and interpret engineering drawings, including basic GD&T.
- Proficient in using precision measuring instruments, including but not limited to calipers, micrometers, height gauges, bore gauges, thread gauges, plug gauges, ring gauges, dial indicators, and surface roughness testers.
- Ability to perform dimensional inspection using Coordinate Measuring Machines (CMM) (Hexagon preferred).
- Ability to measure…
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