Quality Engineer - Medical Device Manufacturer

Job Title

Device and Complaint Investigation

About Our Client

Our client is a medical device manufacturer with expertise in electro-mechanical manufacturing. As the company expands through the launch of an innovative new product line, they are seeking a professional who will play a key role in supporting this growth. ISO 13485 certified, the organization delivers products and services to customers in nearly 50 countries and offers the opportunity to make a meaningful impact on patients' lives around the world.

Job Description

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. Evaluate complaint, service, repair, and failure data to identify recurring issues, emerging risks, and adverse quality trends. Develop and report KPI metrics for Complaint Review Boards, CAPA Reviews, Management Reviews, Quality System Reviews, and audit support activities. Coordinate and lead Complaint Review Board meetings, including preparation of presentations, trend analyses, action items, and escalation summaries. Support CAPA Review Board activities by tracking progress, effectiveness, priorities, aging actions, and cross-functional follow-up requirements. Assess complaint and CAPA outcomes for their impact on product risk profiles, hazard analyses, risk controls, and benefit-risk evaluations. Document and communicate findings that may require updates to risk management files, post-market surveillance activities, and quality system documentation. Participate in internal and external audits, regulatory inspections, and management review activities to support ongoing compliance and quality excellence.

The Successful Applicant

Bachelor's Degree (Engineering-related preferred). 4+ years of manufacturing experience within 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. CQE certification is preferred. Six Sigma belt is preferred. Sponsorship is not provided.

What's on Offer

Base salary between $100k-$115k. Health, dental, vision. 401(k) matching. 3 weeks PTO. 4% annual bonus incentive.

Job Summary

Sector: Engineering & Manufacturing. Sub Sector: Quality, Technical. Industry: Industrial / Manufacturing. Where: Wood Dale. Contract Type: Permanent. Consultant name: Collin Patrick Walsh. Job Reference: JN-092026-7100298