Quality Inspector for Medical Devices

A Quality Inspector for Medical Devices is responsible for performing inspections and tests on raw materials, in-process components, and finished products to ensure compliance with industry standards and regulatory requirements. This role involves using precision measuring tools, interpreting technical drawings and specifications, and meticulously documenting results in accordance with FDA regulations and ISO 13485 quality management systems.

In addition to identifying and reporting product defects or process deviations, Quality Inspectors collaborate with engineering, production, and quality teams to implement corrective actions and support continuous improvement initiatives. They may also assist in internal audits, maintain calibration records, and ensure that all testing equipment and procedures meet Good Manufacturing Practice (GMP) standards.

Key Responsibilities

1. Inspection of Products

   • Perform visual and mechanical inspections of raw materials, in-process components, and finished medical devices.

   • Use tools like calipers, micrometers, gauges, and test fixtures.

2. Testing

   • Conduct functional tests, measurements, and sampling according to product specifications.

   • Identify defects such as contamination, dimensional inaccuracies, or functional failures.

3. Documentation & Recordkeeping

   • Maintain accurate inspection records, including Device History Records (DHRs).

   • Log non-conformances and create Non-Conformance Reports (NCRs).

4. Compliance & Auditing

   • Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and cGMP requirements.

   • Assist in internal and external audits.

5. Process Improvement

   • Work with engineers and production staff to correct recurring issues.

   • Recommend quality improvements and participate in CAPA (Corrective and Preventive Actions) processes.

6. Calibration & Equipment Checks

   • Ensure that inspection and test equipment are calibrated and maintained properly.

Medical Device Examples

• Surgical instruments

• Catheters

• Pacemakers

• Diagnostic equipment

• Disposable medical supplies (e.g., syringes, tubing)

Education & Certification

• • Education: High school diploma required; associate degree in Quality Assurance, Engineering Technology, or a related field preferred.

  • Certifications (optional but valuable):

    • CQI (Certified Quality Inspector – ASQ)

    • CQT (Certified Quality Technician – ASQ)

    • ISO 13485 internal auditor certification

Skills Required

• • • • Attention to detail

      • Familiarity with inspection tools and test equipment

      • Understanding of engineering drawings and technical specs

      • Basic knowledge of statistical process control (SPC)

      • Communication and teamwork

      • Documentation and data entry accuracy

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???? Common Work Environments

• • • • Medical device manufacturing plants

      • Cleanrooms and sterile environments

      • Quality control laboratories

      • Incoming inspection departments

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???? Sample Tools & Software

• • • • Micrometers, calipers, pin gauges

      • CMM (Coordinate Measuring Machines)

      • ERP and MES systems (e.g., SAP, Oracle)

      • Quality Management Software (e.g., MasterControl, TrackWise)