Senior Quality Engineer - Product Development
Core
Senior Quality Engineer leading risk management, design validation, and process validation for combination products in medical device development.
Role type
Senior IC Quality Engineer (Product Development)
Builds
New medical device combination products and manufacturing processes
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk assessment and management, Design validation and verification, Process validation, Component qualification, Root cause analysis, Statistical analysis, Regulatory compliance (ISO 13485, 21 CFR), Manufacturing control planning, Supplier audit coordination
Preferred skills
Pharmaceutical or combination product experience, ASQ Quality Engineering Certification
Technologies
ISO 13485, ISO 14971, 21 CFR 210/211/820, Sampling Plans, Test method development
Responsibilities
Lead development of risk assessments and test methods, Lead component qualifications and design validation, Lead product investigations, Translate design inputs into manufacturing control plans, Coordinate product development activities for a product line, Support regulatory department in writing technical submissions
Seniority
Senior, hands-on IC
