Design Quality Engineer III
Core
Design Quality Engineer for medical device sustaining engineering projects, ensuring compliance with FDA and ISO regulations through design controls, risk management, and CAPA activities.
Role type
Senior Design Quality Engineer (Level III)
Builds
Quality plans, design and development files (DDFs), risk assessments, and CAPA investigations for MedTech products.
Domain
Medical Technology / Regulatory Quality Engineering
Deliverable
product features
Required skills
Design controls, Risk management (ISO 14971), FDA QSR (21 CFR 820), ISO 13485, CAPA investigations, FMEA, Hazard Analysis, Field issue assessments, Audit participation, Quality system development
Preferred skills
Statistical analysis (Minitab, JMP), ASQ certification (CQE, CRE, CMQ/OE)
Technologies
Minitab, JMP
Responsibilities
Execute design reviews and verification/validation, maintain DDFs, perform risk-benefit analysis, investigate complaints and field issues, conduct internal/external audits, mentor junior engineers
Seniority
Senior, hands-on IC with mentorship duties
