Quality Engineering Manager
Core
Lead the development and implementation of the Quality Management strategy for the WWISD Design Center, ensuring compliance with medical device regulations and supporting new product 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, Root Cause Investigation, CAPA, Supplier Qualification, Post Market Surveillance, Strategic Planning, Team Leadership
Preferred skills
Six Sigma Green/Black Belt, DFSS, Manufacturing experience, Project Management
Technologies
21 CFR 820, ISO 13485, ISO 14971, ISO 10993
Responsibilities
Lead development and continuous improvement of quality systems compliant with 21 CFR 820 and ISO 13485; Execute and report on Quality strategic initiatives; Lead Risk Management activities; Develop department skills and resources; Lead a team of Quality Engineers; Serve as a Subject Matter Expert for Design Controls.
Seniority
Manager, direct leadership of QA professionals