Quality Assurance & Reliability Engineer

Job overview

The Quality Assurance & Reliability Engineer role is onsite in Morrisville, NC; compensation is not specified. The position supports quality management and post-market quality activities for Class I medical devices in the United States and Canada. Spencer Health Solutions develops technology that connects patients, clinicians, pharmacists, and family members to support care at home. The role maintains and improves quality processes while analyzing field-performance data to identify reliability concerns and guide risk-based corrective action. It investigates complaints, failures, and nonconformances, and works across functions to verify improvements.

What you'll do

• Execute and improve QMS processes, controlled records, training, internal audit support, quality metrics, and management review inputs. Qualify and monitor suppliers, conduct supplier audits, and manage supplier corrective actions. Investigate complaints and nonconformances, determine root causes, and plan corrective actions. Monitor device failures, returns, service data, software and firmware logs, and complaint trends
• lead cross-functional failure investigations and verify improvements.

What we're looking for

Skills & competencies

quality assurance

reliability engineering

medical devices

quality management system

capa

supplier quality

root cause analysis

field performance data

morrisville nc

custom health

iso 13485

fda qmsr

Work arrangement

• Weekend coverage required

Why this role

Supports post-market quality and reliability for connected Class I medical devices, using field-performance data to identify emerging issues.

About the employer

Custom Health is hiring for this role. Industry: Engineering Services. Sector: 54.