Quality Manager
Core
Manage Quality Engineering, Supplier Quality, Regulatory Compliance, and Analytical laboratories to support Manufacturing and New Product Development.
Role type
Senior Quality Manager
Builds
High quality medical device products compliant with FDA and ISO regulations
Domain
Medical Devices / Pharmaceutical Quality
Required skills
People leadership, Quality systems knowledge, Regulatory compliance, Laboratory operations, Audit management, Supplier quality management, Budget management, Strategic planning
Preferred skills
Stakeholder management, Change leadership, Innovation
Technologies
None stated
Responsibilities
Recruit and develop organizational talent, Foster a diverse workplace, Provide direction to exempt specialists, Monitor compliance with FDA and BSI requirements, Manage annual budget, Approve quality system documents, Review supplier quality systems, Resolve quality and reliability issues, Ensure valid test data for regulatory submissions, Oversee Annual Product Review process
Seniority
Senior, hands-on IC with management responsibilities