Quality Control Inspector

Responsibilities

• Perform incoming, in-process, and final inspections of components, subassemblies, and finished medical devices.
• Utilize measuring equipment including calipers, micrometers, microscopes, pin gauges, snap gauges, CMMs, Instron testers, and other inspection tools.
• Review engineering drawings, inspection plans, and quality documentation to verify product compliance.
• Complete and maintain accurate inspection records following Good Documentation Practices (GDP).
• Review Device History Records (DHRs) and other quality documentation to support product release.
• Identify nonconforming materials and support rework, rejection, and disposition activities.
• Inspect and support the maintenance and calibration of inspection equipment and fixtures.
• Assist with investigations, corrective actions, and continuous improvement initiatives.
• Follow Quality Management System (QMS) procedures while maintaining compliance with regulatory requirements.
• Work safely and effectively within a cleanroom manufacturing environment.

Required Qualifications

• 3–6 years of quality inspection experience within a regulated manufacturing environment.
• Experience using precision measuring equipment such as: Microscopes, Calipers, Micrometers, Pin gauges, Snap gauges, CMM, Instron testers.
• Experience with Good Documentation Practices (GDP).
• Experience reviewing quality documentation such as:
  • Device History Records (DHR)
  • Device Master Records (DMR)
  • Inspection plans
  • Engineering drawings
• Strong attention to detail and documentation skills.
• Comfortable working in a cleanroom environment.
• Proficiency with Microsoft Excel and Word.