Medical Device QA & Reliability Engineer

Custom Health; Morrisville (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Spencer Health Solutions seeks a Quality Assurance & Reliability Engineer to support QMS for Class I medical devices in the US and Canada. You will use field data to drive risk-based CAPA and improvements across supplier quality, investigations, and product reliability.

Responsibilities include executing QMS processes, audits, and management reviews, with cross-functional collaboration to identify and address quality risks and trends.

Qualifications

• 3+ years of Quality Engineering/QA in a regulated manufacturing environment.
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820 / QMSR; audit-ready records.
• Hands-on CAPA, nonconformance, complaint handling, root-cause investigation, supplier quality.
• Strong data analysis to interpret defect and failure rates; proficient in Excel.
• Structured problem solving methods and cross-functional communication skills.
• Bachelor’s degree in a technical discipline; relevant experience considered.

Responsibilities

• Execute and improve QMS processes, records, training, audits, metrics, and mgmt reviews.
• Perform risk-based supplier qualification, audits, and supplier corrective actions.
• Investigate quality events; plan corrective actions and mitigations.
• Monitor device reliability, analyze field data, and define meaningful metrics.
• Lead cross-functional investigations and verify improvements.

Skills

Analytical skills

Documentation & writing

Cross-functional communication

Excel / data analysis

Education

Bachelor’s degree in Engineering, Quality, Biomedical, Electrical, Mechanical, Computer/Software Engineering

Tools

CAPA systems

Nonconformance handling

Statistical analysis tools (Minitab, Python, SQL)

Job description

Spencer Health Solutions seeks a Quality Assurance & Reliability Engineer to support QMS for Class I medical devices in the US and Canada. You will use field data to drive risk-based CAPA and improvements across supplier quality, investigations, and product reliability.

Responsibilities include executing QMS processes, audits, and management reviews, with cross-functional collaboration to identify and address quality risks and trends.