Quality Engineering Manager
Core
Lead quality engineering strategy, system compliance, and risk management for medical device design and development.
Role type
Manager, Quality Engineering (Medical Devices)
Builds
Compliant medical device products and quality management systems
Domain
Medical Technology / Regulatory Compliance
Required skills
Quality Management Systems (QMS), Risk Management (ISO 14971), Design Controls, Statistical Analysis, CAPA, Root Cause Investigation, Process Validation, Supplier Qualification, Post Market Surveillance, Strategic Planning
Preferred skills
Six Sigma Green/Black Belt, DFSS, Manufacturing Project Management
Technologies
21 CFR 820, ISO 13485, ISO 10993
Responsibilities
Lead development and continuous improvement of quality systems; Execute and report on quality strategic initiatives; Lead Risk Management activities; Develop technical solutions to complex quality problems; Lead a team of Quality Engineers; Serve as Subject Matter Expert for Design Controls.
Seniority
Manager, direct leadership