Advanced Engineer DQA
Core
Own project management and product development testing strategies to minimize failures during new product introduction (NPI) for medical devices.
Role type
Senior Quality Assurance Engineer (Medical Devices)
Builds
Medical device products compliant with regulatory standards
Domain
Medical Devices / Quality Engineering
Deliverable
product features
Required skills
Project management, statistical quality tools, supplier quality management, regulatory compliance (ISO 13485/9001), risk management, design control, FMEA, Control plan, MSA, PPAP
Preferred skills
Experience with 510(k) and CE Technical Files, cross-functional leadership
Technologies
MS Office, Adobe tools
Responsibilities
Define testing strategies for NPI, develop standardized process control and validation methods, execute experimental testing and data analysis, resolve customer complaints and drive CAPA/SCAR, manage supplier change requests, establish compliant product documentation for regulatory submissions, conduct quality reviews of design documentation, coordinate product testing with internal and external laboratories
Seniority
Senior, hands-on IC
