Senior Design Quality Engineer
Core
Senior Design Quality Engineer supporting sustaining and lifecycle management of Sports Medicine Joint Repair products, ensuring safety, effectiveness, and compliance.
Role type
Senior Design Quality Engineer (Medical Devices)
Builds
Sports Medicine Joint Repair products
Domain
Medical Devices / Orthopedics / Joint Repair
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management (FMEA, ISO 14971), Design controls (FDA QSR, ISO 13485), CAPA, Validation activities (Design, Process, Sterilization), Supplier qualification, Change control, Root cause analysis, Regulatory submissions support
Preferred skills
CQE certification, Six Sigma certification
Technologies
FDA QSR, ISO 13485, ISO 14971
Responsibilities
Lead risk management activities including FMEA development and risk control implementation; Provide design quality oversight for verification, validation, and process changes; Lead investigations for complaints, nonconformances, and post-market surveillance; Review and approve quality and engineering documentation for compliance; Partner with cross-functional teams on regulatory submissions and audits; Drive continuous improvement through quality data analysis; Provide technical leadership and mentorship to the team
Seniority
Senior, hands-on IC with mentorship responsibilities
