Quality Engineer, Med Device — Complaints & CAPA Leader

Michael Page; Elk Grove Village (IL); On-site; USD 100,000 - 115,000; Full time

Benefits offered by this job

401(k) matching

4% annual bonus incentive

Job summary

MPI is seeking a Quality Engineer in the United States (Illinois) to own complaint handling and lead CAPA investigations for a medical device product line. You will collaborate with Customer Support, Engineering, Manufacturing, and Quality to drive timely issue resolution and regulatory readiness.

The role requires 4+ years in manufacturing quality, ISO 9001/14971 awareness, and electro-mechanical device experience. Base salary ranges from $100k to $115k with bonus and 401(k) matching.

Qualifications

• Bachelor's degree in engineering-related field or equivalent.
• 4+ years of manufacturing experience in quality.
• Understanding of ISO 9001.
• Experience with electro-mechanical processes.
• Medical device experience is preferred.
• Combination device experience is preferred.
• Experience working with capital equipment.
• Experience working with sterile products is preferred.
• Understanding of ISO 14971 and UL 60601 is preferred.
• Six Sigma belt is preferred.
• Sponsorship is not provided.

Responsibilities

• Investigate and manage product complaints involving capital equipment, disposable products, serviced devices, field reports, and customer-reported issues while ensuring compliance with quality and regulatory requirements.
• Partner with Customer Support, Engineering, Manufacturing, Quality, and other cross-functional teams to assess complaints, determine investigation scope, prioritize risk, and involve suppliers when necessary.
• Escalate critical safety concerns, major quality issues, and investigation roadblocks to appropriate stakeholders in accordance with established procedures.
• Support regulatory reporting evaluations by maintaining thorough documentation and providing technical data needed for Quality and Regulatory decision-making.
• Maintain accurate, complete, and audit-ready complaint records, including investigation findings, root cause analysis, classifications, corrective actions, and customer communications.
• Ensure complaint investigations are closed in a timely manner and linked to risk management, CAPA, trend analysis, and continuous improvement initiatives.
• Lead or support Corrective and Preventive Action (CAPA) activities resulting from complaint investigations and identified quality trends.
• Drive escalations for issues requiring improvements to products, processes, suppliers, servicing, labeling, design, or quality systems.
• Analyze complaint, CAPA, nonconformance, supplier, and post-market data to identify opportunities for quality and operational improvements.

Job description

MPI is seeking a Quality Engineer in the United States (Illinois) to own complaint handling and lead CAPA investigations for a medical device product line. You will collaborate with Customer Support, Engineering, Manufacturing, and Quality to drive timely issue resolution and regulatory readiness.

The role requires 4+ years in manufacturing quality, ISO 9001/14971 awareness, and electro-mechanical device experience. Base salary ranges from $100k to $115k with bonus and 401(k) matching.