Position Summary
The Quality Inspector ensures that medical devices and components consistently meet internal specifications, customer requirements, and regulatory standards. This role is critical to maintaining product quality, reliability, and patient safety in compliance with FDA 21 CFR Part 820, ISO 13485, and cGMP requirements.
Key Responsibilities
Inspect incoming materials, in-process assemblies, and finished medical devices using visual, mechanical, and electronic methods.
Verify product specifications using precision tools (e.g., calipers, micrometers, multimeters).
Read and interpret technical drawings, schematics, and GD&T symbols.
Document inspection results, complete inspection reports and nonconformance reports (NCRs), and ensure accurate records in ERP/QMS systems.
Identify and escalate non-conformances; support root cause analysis and corrective/preventive actions (CAPA).
Verify calibration status of inspection and test equipment prior to use.
Support internal and external audits through preparation of documentation and active participation.
Maintain organized inspection stations and ensure compliance with QMS procedures.
Collaborate with engineering and production teams to resolve quality issues and drive improvements.
Contribute to continuous improvement initiatives, including 5S, Lean, and Kaizen.
Qualifications
Required:
High school diploma or GED; Associate degree or technical certification in quality, electronics, or manufacturing preferred.
2+ years of quality inspection experience in a regulated industry
Strong knowledge of mechanical drawings, GD&T, and inspection tools (calipers, micrometers, multimeters).
Familiarity with FDA regulations, ISO 13485, and cGMP.
Experience using ERP/QMS systems (e.g., SAP, IQMS, or similar).
Strong attention to detail, communication, and problem-solving skills.
Preferred:
IPC certification (e.g., IPC-A-610).
Experience with imaging systems or advanced inspection technology.
Training in root cause analysis tools (5 Whys, Fishbone Diagram, etc.).
Working Conditions
Primarily based in a manufacturing/production environment with exposure to inspection equipment and production tools.
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