Quality Assurance Engineer
Core
Investigate product failures, analyze post-market complaint data, and manage quality documentation to ensure regulatory compliance in a regulated industry.
Role type
Senior Quality Assurance Engineer (Regulatory)
Builds
Quality documentation, corrective and preventive actions, and product improvement strategies
Domain
Medical devices / Pharmaceuticals / Regulated industries
Required skills
Root cause analysis, technical documentation review, CAPA process management, change control review, risk management documentation, data trending, cross-functional collaboration
Preferred skills
Medical device or pharmaceutical industry experience, TrackWise or similar QMS familiarity, nonconformance management, commercial product holds management
Technologies
TrackWise
Responsibilities
Investigate product failures by reviewing design history, manufacturing records, and field performance data; Analyze and trend post-market product complaint data; Review and support quality documentation including nonconformance records and engineering change control documents; Guide nonconformance and CAPA processes; Review change control requests to ensure quality system requirements are met; Update risk management documents; Coordinate with Recall Team for field action assessments; Provide quality expertise to engineering and commercial teams
Seniority
Senior, hands-on IC