Sr. Quality Engineer- Surgical Instruments
Core
Establishing quality standards, validating processes, and managing supplier quality for surgical instruments and medical devices.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Production processes, testing methods, and regulatory documentation for surgical instruments.
Domain
Medical Devices / Surgical Instruments
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical process control (SPC), experimental design, CAPA management, regulatory compliance (21 CFR 820, ISO13485), supplier qualification, risk management, data analysis
Preferred skills
Six Sigma/Lean concepts, advanced medical device industry experience
Technologies
MS Office Suite (Excel, Word, PowerPoint, Outlook)
Responsibilities
Develop and implement process control and validation methods; Design complex experiments to analyze process variation; Lead supplier quality programs and corrective actions; Ensure compliance with domestic and international regulations; Lead investigations of non-conformances and develop CAPA; Coordinate product testing with internal and external laboratories.
Seniority
Senior, hands-on IC