Medical Device QA & Reliability Engineer

Community Pharmacy of Smyrna LLC; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Spencer Health Solutions seeks a Quality Assurance & Reliability Engineer to support the QMS and post-market activities for Class I medical devices in the US and Canada. You will analyze field data and failures to identify reliability signals and drive risk-based corrective actions.

The role collaborates with cross-functional teams to improve CAPA, supplier quality, and regulatory compliance while maintaining audit-ready records and robust quality metrics.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• Experience with ISO 13485 and FDA QMSR (21 CFR Part 820).
• Hands-on CAPA, nonconformance, and root-cause investigation experience.
• Proficient in analyzing defect/failure data and trend data.

Responsibilities

• 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.
• Perform risk-based supplier qualification, requalification, performance monitoring, and supplier audits; manage supplier corrective actions and recurring supplier-related quality issues.
• 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.
• 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.
• Lead cross-functional failure investigations, including issue reproduction and hardware/software/system failure analysis, and drive corrective actions plus verification of improvements.

Skills

Quality Engineering

Quality Assurance

CAPA

Root-cause analysis

Statistical analysis

Excel

Education

Bachelor’s degree in Engineering

Engineering degree in Biomedical/Electrical/Mechanical/Computer

Tools

Excel

Power BI

Tableau

SQL

Python

Job description

Spencer Health Solutions seeks a Quality Assurance & Reliability Engineer to support the QMS and post-market activities for Class I medical devices in the US and Canada. You will analyze field data and failures to identify reliability signals and drive risk-based corrective actions.

The role collaborates with cross-functional teams to improve CAPA, supplier quality, and regulatory compliance while maintaining audit-ready records and robust quality metrics.