Our medical manufacturing client is looking for a detail-oriented Quality Inspector to join their team. The Quality Inspector will be responsible for performing inspections and tests on raw materials, in-process components, and finished medical devices to ensure compliance with company standards, regulatory requirements, and customer specifications. The role requires meticulous attention to detail, knowledge of inspection techniques, and a commitment to maintaining the highest product quality.

Responsibilities

• Perform incoming, in-process, and final inspections of medical devices (e.g., endoscopes) using tools such as calipers, micrometers, microscopes, gauges and other optical instruments and devices.
• Verify components and assemblies against engineering drawings, specifications, and tolerances.
• Conduct functional testing as required and document results accurately.
• Maintain detailed and accurate inspection records, including test results, nonconformances, and completed checklists.
• Generate inspection reports and ensure traceability of inspected items.
• Identify and report non-conforming products or materials.
• Collaborate with the Quality Control Engineer to address non-conformance issues, including initiating CAPA processes where applicable.
• Ensure all inspections align with company SOPs, ISO 13485 standards, and FDA QSR requirements.
• Support internal and external audits by providing inspection records and data.
• Calibrate and maintain inspection tools and equipment as per schedule.
• Ensure all equipment used for inspections meets required accuracy standards.
• Provide feedback to the Quality and Manufacturing teams regarding recurring issues or potential areas for process improvement.
• Participate in training sessions and quality improvement initiatives

Qualifications

• High school diploma or equivalent required; technical training in quality or manufacturing is a plus
• 1+ year of experience as a Quality Inspector, preferably in the medical device or regulated industry.
• Familiarity with medical device environments and inspection processes.
• Proficiency with inspection tools (e.g., calipers, micrometers, microscopes).
• Ability to read and interpret engineering drawings, including GD&T symbols.
• Strong attention to detail, organizational skills, and ability to work independently.
• Certified Quality Inspector (CQI) or equivalent certification preferred
• Bilingual in English and Chinese preferred