Quality Manager
Core
Manage Quality Engineering, Supplier Quality, Regulatory Compliance, and Analytical laboratories to support Manufacturing and New Product Development while ensuring FDA and ISO compliance.
Role type
Senior Quality Manager (Operations)
Builds
High-quality medical device products and compliant quality systems
Domain
Medical devices / Pharmaceutical / Regulated laboratory operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People leadership, regulatory compliance management, supplier quality oversight, budget management, audit management, strategic planning, stakeholder collaboration, change leadership
Preferred skills
Experience with regulatory submissions, quality improvement initiatives, diverse workplace development
Technologies
None stated
Responsibilities
Recruit and develop technical teams, monitor compliance with FDA/ISO requirements, manage departmental budgets, approve quality system documents, review supplier quality systems, resolve quality and reliability issues, oversee Annual Product Review process
Seniority
Senior, hands-on IC with strategic oversight
