Staff Quality Engineer
Core
Senior technical leader ensuring compliance with medical device regulations and quality management systems while supporting manufacturing operations and new product introductions.
Role type
Staff Quality Engineer (Medical Device Manufacturing)
Builds
compliant medical devices and manufacturing processes
Domain
MedTech / Healthcare / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
FDA 21 CFR Part 820, ISO 13485, Risk Management (ISO 14971), CAPA, Root Cause Analysis, Design Controls, Design Transfer, Statistical Analysis, Lean Six Sigma
Preferred skills
Capital equipment experience, FDA inspection support, Notified body audits, Advanced Quality Engineering techniques
Technologies
5 Why, Fishbone, Fault Tree Analysis, DOE
Responsibilities
Lead root cause investigations for manufacturing nonconformances; Ensure compliance with FDA 21 CFR Part 820 and ISO 13485; Lead internal and external audits and corrective actions; Drive strategic quality improvement initiatives using Lean and Six Sigma; Provide quality engineering leadership during new product development and design transfer.
Seniority
Staff, technical leadership & mentorship