Quality Assurance & Reliability Engineer
Custom Health · SHS Morrisville ·
- Category
- QA
About Spencer
Spencer Health Solutions (www.spencerhealthsolutions.com) is transforming healthcare by moving care delivery to the home through the company’s spencer® medication adherence and engagement platform. The spencer FDA Class I technology enables virtual care by connecting patients, clinicians, pharmacists and family members digitally.
The Morrisville company offers the right candidate an opportunity to be part of a high-performing team in the development of cutting-edge medical technology at the exciting point of market entry through leading health technology distributors in the US, Canada and Europe.
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.