Quality Associate

Job Title:
Quality Associate – Returned Product Investigation (Medical Devices)

Location: Minneapolis, MN

Duration: Contract

Our medical device client is seeking a Quality Associate with 1–3 years of experience supporting returned product investigations in a regulated medical device environment. The ideal candidate will have experience evaluating returned products, documenting investigation results, identifying product failures, and supporting quality system processes while ensuring compliance with FDA and ISO quality standards.

• Perform investigations on returned medical devices to determine product performance and failure modes.
• Inspect, test, and evaluate returned products using established inspection and investigation procedures.
• Document investigation findings accurately and prepare detailed technical reports.
• Identify product defects, nonconformances, and potential failure mechanisms.
• Support root cause analysis (RCA) activities using standard problem-solving methodologies.
• Assist with complaint investigations and product failure analysis.
• Generate and maintain quality records in compliance with internal procedures and regulatory requirements.
• Support CAPA (Corrective and Preventive Action) activities by providing investigation data and technical input.
• Process and document Nonconforming Material Reports (NCMR/NCR) as required.
• Collaborate with Quality, Manufacturing, Engineering, Regulatory Affairs, and Supplier Quality teams to resolve product quality issues.
• Ensure compliance with FDA 21 CFR Part 820
  , ISO 13485
  , and company Quality Management System (QMS) requirements.
• Maintain accurate documentation in electronic quality management systems.
• Participate in continuous improvement initiatives to enhance investigation processes and product quality.
• Assist during internal and external quality audits by providing investigation records and supporting documentation.
• Follow Good Documentation Practices (GDP) and company quality procedures at all times.

• Associate's or Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical field (or equivalent experience).
• 1–3 years of experience in a medical device manufacturing or quality environment
  .
• Hands‑on experience performing returned product investigations or product failure analysis
  .
• Working knowledge of FDA 21 CFR Part 820
  , ISO 13485
  , and Quality Management Systems.
• Experience documenting investigations and maintaining quality records.
• Familiarity with Root Cause Analysis (RCA) techniques.
• Strong analytical, troubleshooting, and problem‑solving skills.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office applications.

• Experience with CAPA
  , Complaint Handling
  , NCR/NCMR
  , and Nonconformance Investigations
  .
• Knowledge of medical device manufacturing processes and quality inspection techniques.
• Experience using electronic Quality Management Systems (eQMS).
• Familiarity with statistical analysis and continuous improvement methodologies.
• Understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).