LCM Sr Quality Engineer
Core
Develop quality-engineered systems and products for medical devices, ensuring compliance with FDA, ISO 13485, and other regulatory standards throughout the product lifecycle.
Role type
Senior Individual Contributor Quality Engineer (Medical Devices)
Builds
Medical device products and manufacturing processes
Domain
MedTech / Healthcare / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Engineering tools, Design Control, Verification and Validation (V&V), Statistical Analysis (Six Sigma, SPC, DOE), Risk Management, CAPA, Vendor Auditing, Regulatory Compliance (FDA, ISO 13485, MDR), Process Validation, Equipment Qualification
Preferred skills
ASQ Certification, Six Sigma Black Belt, GD&T, Lean Manufacturing, Project Management
Technologies
SPC, DOE, Six Sigma tools
Responsibilities
Lead design verification tests and process validations; Write and approve validation protocols and reports; Analyze data to improve process capability; Determine sterility and packaging test requirements; Support vendor audits and supplier quality; Investigate Corrective and Preventative Actions (CAPA); Supervise inspectors and technicians
Seniority
Senior, hands-on IC with supervisory responsibilities