Quality Engineer
Core
Ensuring product manufacturing aligns with quality and regulatory standards for ophthalmic surgical devices.
Role type
Quality Engineer (Medical Device Manufacturing)
Builds
Ophthalmic surgery units, instruments, and liquids
Domain
Medical Technology / Ophthalmic Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process validation, risk management (PFMEA), quality inspections, inventory control, design transfer, nonconformance investigation, CAPA management, supplier quality management, 3rd party audit participation, procedure validation
Preferred skills
Auto CAD, Solid Works, ERP systems, microscope operation
Technologies
Microsoft Office, Auto CAD, Solid Works, ERP
Responsibilities
Identify and assist with process validation activities; Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA); Inspect product including labeling and documentation for release of finished goods; Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs; Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.); Assist with revisions and updates to quality procedures, standardized work instructions
Seniority
Mid-Senior, hands-on IC
