Medical Device Quality Inspector

Job Title: Medical Device Quality Inspector
Location: Madison, WI 53718, USA
Department: Quality Control
Reports To: Quality Control Manager


Job Summary

The Medical Device Quality Inspector is responsible for ensuring that all materials, processes, and procedures related to device manufacturing, processing, and packaging comply with current Good Manufacturing Practices (GMP) and meet internal quality standards, as well as the FDA Quality System Regulations and ISO 13485 standards. The role ensures the quality and integrity of medical devices through detailed inspections, documentation reviews, and adherence to regulatory requirements.


Essential Functions

• Perform one or more key Quality Control functions:
  • Raw Material Inspection: Verify incoming materials meet required production and quality standards.
  • In-Process Inspection: Conduct in-process evaluations of products and manufacturing processes.
  • Final Documentation Review: Review final packaging, labeling, and documentation for completeness and compliance.
• Assist in documentation control activities within the manufacturing facility.
• Accurately document all inspection and verification activities, ensuring traceability and product labeling integrity.
• Ensure secure and compliant storage and handling of materials and finished goods.
• Support investigations of nonconformances and assist in preventive and corrective actions (CAPA).
• Perform quality reviews for quarantine releases on non-reportable, non-compliant internal RMF-3 events within the RSC.

Minimum Requirements

Education & Experience:

• High school diploma or equivalent required.
• Minimum of one (1) year of experience in a regulated manufacturing environment (medical device or pharmaceutical preferred).
• Working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485 standards.

Skills & Competencies:

• Strong attention to detail and accuracy.
• Highly motivated with the ability to work independently and collaboratively.
• Competent in using computer-based quality and documentation systems.
• Excellent interpersonal, verbal, and written communication skills.
• Strong problem-solving and organizational abilities.

Working Conditions

• Work is performed in a controlled manufacturing environment for medical devices and accessories.
• The position may require standing for extended periods and performing detailed inspections under magnification or controlled lighting.
• Strict adherence to environmental and safety regulations is required.