Senior Quality RI FG Engineer
Core
Senior Quality Engineer responsible for product release decisions, root cause analysis of defects, and validation of processes and equipment in a regulated medical device manufacturing environment.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
compliant medical devices and validated manufacturing processes
Domain
Medical Technology / Regulated Manufacturing
Required skills
Root cause analysis, Product release decision-making, Equipment and test method validation, Statistical analysis, Risk assessment, Engineering drawing interpretation, Six Sigma/Lean principles, Regulatory compliance (QSR, ISO/MDD, BSEN 14971), Incoming and outgoing quality inspection, CAPA management
Preferred skills
SAP knowledge, New product/technology transfer, Training on complaint handling systems, Environmental impact assessment
Responsibilities
Identify and resolve complex exceptions to work assignments, Summarize and analyze test results to make quality decisions, Disposition non-conforming material and lead root cause investigations, Review and develop process validation protocols, Evaluate new equipment and processes for compliance and environmental impact, Conduct incoming and outgoing quality inspections, Provide technical guidance to junior staff, Partner with cross-functional teams to drive continuous improvement
Seniority
Senior, hands-on IC