Quality Inspector I

About the role

The Quality Inspector I ensures that raw materials, in‑process components and finished medical‑device products meet all specifications and regulatory requirements. Working in a regulated manufacturing environment, the inspector conducts inspections, records results and supports compliance with FDA QMSR, 21 CFR Part 820 and ISO 13485.

Key responsibilities

• Perform visual, dimensional and functional inspections of incoming materials, in‑process parts and finished goods using calibrated tools such as calipers, micrometers and gauges.
• Review Device History Records, batch records and other quality documentation for completeness and compliance.
• Identify, document and escalate non‑conforming items, support material segregation, and assist with non‑conformance reports and investigations.
• Conduct in‑process and final audits to verify adherence to manufacturing procedures and quality standards.
• Record inspection and test results in electronic or paper systems following Good Documentation Practices.
• Support line‑clearance activities, equipment calibration checks and clean‑room contamination controls.
• Collaborate with Manufacturing, Engineering and Quality Engineering to resolve quality issues and drive continuous improvement.
• Assist with internal audits, external regulatory inspections and customer audits as required.

Required profile

• Working knowledge of GMP, GDP and basic quality‑system requirements.
• Familiarity with FDA 21 CFR Part 820 and ISO 13485 standards (preferred).
• Ability to read and interpret engineering drawings, specifications and inspection criteria.
• Strong attention to detail and ability to detect defects.
• Effective written and verbal communication skills.
• Ability to work independently and as part of a team in a fast‑paced, regulated environment.

Required skills

• Calipers
• Micrometers
• Gauges
• Measurement instruments
• Microsoft Office
• Electronic quality management systems