Sr. Quality Engineer
Core
Sr. Quality Engineer enabling the Advanced Tissue Models team to establish optimum quality control in product manufacturing and design control for porcine-derived and synthetic surgical training tissue models.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Porcine-derived and synthetic surgical training tissue models and supporting equipment
Domain
Medical Devices / Surgical Training
Required skills
21 CFR 820, ISO 13485, ISO 14971, Design Controls, Risk Management (FMEA), Process Validation, Root Cause Analysis, SPC, Six Sigma (DMAIC), Failure Analysis
Preferred skills
Advanced degree in Engineering/Life Sciences
Technologies
Excel (Pareto, charts, trends), Engineering Change Orders
Responsibilities
Support new product development design controls and risk management; Support manufacturing processes, failure analysis, and defect containment; Lead quality initiatives and continuous improvement projects; Support internal and external audits; Perform deep technical failure analysis based on physics of failure.
Seniority
Senior, hands-on IC