Overview The Quality Assurance & Reliability Engineer supports the Quality Management System (QMS) and post-market quality activities for Class I medical devices in the United States and Canada. The role facilitates core quality processes and uses field-performance data-such as device error rates, failures, returns, service records, and complaints-to identify emerging reliability issues and drive risk-based corrective action.
Key Responsibilities- QMS - Execute and improve QMS processes, controlled records, training, internal audit support, quality metrics, and management review inputs in alignment with applicable ISO 13485, FDA QMSR (21 CFR Part 820), and Health Canada requirements.
- Supplier Quality - Perform risk-based supplier qualification, requalification, performance monitoring, and supplier audits; manage supplier corrective actions and recurring supplier-related quality issues.
- Quality Events & CAPA - Collect, investigate, and determine root cause for product complaints, nonconformances, and other quality events; plan and execute corrective actions and mitigations based on risk, recurrence, and emerging quality or reliability trends.
- Reliability & Field Data - Monitor device error/failure rates, returned-product findings, service data, software/firmware logs, and complaint trends; define meaningful metrics and alert thresholds to identify potential reliability signals.
- Reliability Investigations - Lead cross-functional failure investigations, including issue reproduction and hardware/software/system failure analysis, and drive corrective actions plus verification of improvements.
Requirements
Required Experience & Qualifications- Experience: 3+ years of Quality Engineering, Quality Assurance, or related experience in a regulated manufacturing environment.
- QMS & Compliance: Working knowledge of ISO 13485 and applicable U.S. medical-device quality requirements, including FDA 21 CFR Part 820 / QMSR; ability to maintain complete, audit-ready quality records.
- Quality Systems: Hands-on experience with CAPA, nonconformance, complaint handling, root-cause investigation, and supplier qualification or supplier quality management.
- Analytical Skills: Ability to calculate and interpret defect/error/failure rates, trend field and quality data, identify outliers or adverse signals, and distinguish normal variation from potential reliability issues. Strong Excel or equivalent analytical-tool proficiency.
- Problem Solving & Communication: Experience with structured root-cause methods (for example 5 Why, fishbone, Pareto, 8D, fault-tree analysis, or FMEA) and strong technical writing/cross-functional communication skills.
- Education: Bachelor's degree in Engineering, Quality, Biomedical, Electrical, Mechanical, Computer/Software Engineering, or a related technical discipline; equivalent relevant experience may be considered.
Preferred Experience- Medical Devices: Experience in medical-device manufacturing, particularly with products that combine hardware, embedded software/firmware, and connected or data-producing components.
- Hardware & Software: Ability to interpret service data and engineering test results to collaborate on investigations involving electronics, mechanical systems, embedded software, communications, or system integration.
- Standards: Familiarity with ISO 14971 and IEC 62304, and with IEC 60601 where applicable to the product.
- Data & Credentials: Experience with statistical/reliability analysis tools (such as Minitab, SQL, Python, Power BI/Tableau, or similar) and/or ASQ CQE or ISO 13485 auditor training.
