Quality Inspector (11369)

Job Description

Job Description

Quality Inspector
Reno, NV
Starting Pay: $20.00/hour

About the role:

The Quality Inspector is 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.

Key Responsibilities:
1. Inspection and Testing

• 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.

2. Documentation and Record-Keeping

• Maintain detailed and accurate inspection records, including test results, non-conformances, and completed checklists.
• Generate inspection reports and ensure traceability of inspected items.

3. Non-Conformance Handling:

• 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.

4.Compliance and Standards Adherence

• 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.

5. Equipment Maintenance

• Calibrate and maintain inspection tools and equipment as per schedule.
• Ensure all equipment used for inspections meets required accuracy standards.

6. Continuous Improvement

• 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:

1. Education

• High school diploma or equivalent; technical training in quality or manufacturing is a plus.

2. Experience

• 1+ year of experience as a Quality Inspector, preferably in the medical device or regulated industry.
• Familiarity with medical device environments and inspection processes.

3. Skills

• 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.

4. Certifications (Preferred)

• Certified Quality Inspector (CQI) or equivalent certification.

5. Bi-lingual English and Chinese is not required but helpful.

Military experience equivalency may substitute for some requirements.

We are an equal opportunity employer and will consider all applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, disability and/or other protected categories. We are also committed to providing reasonable accommodation(s) to qualified individuals with disabilities or needs, as required by law.