Senior Quality Engineer - Global Post Market Support
Core
Establish, maintain, and improve process controls for global post-market complaint handling to ensure reliability and regulatory compliance.
Role type
Senior Quality Engineer (Post-Market Surveillance)
Builds
Robust complaint handling processes and documentation for medical device regulatory compliance
Domain
Medical Devices / Quality Engineering
Required skills
Statistical process control (SPC), Root cause analysis, Corrective and preventive actions (CAPA), Cross-functional project management, Regulatory compliance knowledge, Process documentation, Data analysis, Systems thinking
Preferred skills
ASQ Certified Quality Engineer (CQE), Lean Six Sigma, EU MDR, ISO 13485, ISO 14971, Risk management
Technologies
Statistical tools, Standard Operating Procedures (SOPs), Control plans
Responsibilities
Establish process controls for complaint handling outputs, Evaluate end-to-end complaint handling processes, Lead root cause investigations for process failures, Collaborate with Post-Market Surveillance and Risk Management teams, Create and maintain regulatory documentation, Report process trends to senior management, Translate customer needs into process requirements
Seniority
Senior, hands-on IC