QA Engineer (Post Market Quality)
Core
Investigate product failures and customer complaints, perform root cause analysis, and drive corrective actions to ensure post-market safety and compliance.
Role type
Post-market quality engineer (medical device/regulated industry)
Builds
Corrective and preventive actions (CAPA), investigation reports, and quality system improvements
Domain
Medical device / Healthcare / Highly regulated manufacturing
Required skills
Root cause analysis, CAPA management, complaint handling, regulatory compliance, trend analysis, audit support, cross-functional collaboration
Preferred skills
Medical device industry experience, ISO standards knowledge, GMP requirements, data analytics, AI/automation tools
Technologies
Quality management systems, regulatory reporting tools, data analytics platforms
Responsibilities
Review and manage customer complaints, lead product failure investigations, analyze field performance data for trends, maintain quality system documentation, support internal and external audits, collaborate with R&D on design improvements
Seniority
Mid-Senior, hands-on IC