Sr QA Engineer
Core
Ensuring compliance of manufacturing and production processes with safety, quality, and regulatory standards for global distribution of medical devices.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Production processes, inspection methods, and quality assurance protocols for continuous glucose monitoring systems.
Domain
Medical Devices / Biosensing Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Corrective and Preventive Actions (CAPA), Statistical process control, Six Sigma, Lean manufacturing, Total Quality Management, Internal/External auditing, Risk management, Validation, Design verification, Schematic interpretation, Regulatory compliance (FDA 21 CFR 820, ISO 13485)
Preferred skills
Medical Device industry experience, FDA 21 CFR 820 knowledge, ISO 13485 knowledge, Statistical tools (Minitab, JMP, Power BI), Design team participation
Technologies
Minitab, JMP, Power BI, Excel
Responsibilities
Plan and manage compliance of manufacturing processes with regulatory standards; Design methods for inspecting and evaluating production equipment and finished products; Perform analysis of production data to identify trends and update quality standards; Conduct internal audits and support external audits; Lead risk management and validation activities; Improve systems to enhance product safety and production efficiency; Coordinate disposition of nonconforming materials; Participate in design team activities for defining inputs and verifying outputs.
Seniority
Senior, hands-on IC