Quality Systems Manager
Core
Oversee and continuously improve the Quality Management System (QMS) for a regulated medical device environment, ensuring compliance with regulatory requirements and industry standards.
Role type
Senior Quality Systems Manager
Builds
Quality Management Systems, compliance frameworks, and operational effectiveness for medical device products
Domain
Medical Devices / Regulatory Compliance
Required skills
Quality Management System (QMS) oversight, regulatory compliance (FDA 21 CFR, ISO 13485), risk management, supplier quality management, complaint handling, change management, audit leadership, cross-functional collaboration, performance metrics tracking, resource planning
Preferred skills
Advanced degree in Engineering/Life Sciences, regulatory submission support, third-party audit participation, professional certifications (ASQ CQM/CQE/CQA)
Technologies
FDA 21 CFR Parts 820/822/830, ISO 13485, GMP, statistical methods, quality improvement tools
Responsibilities
Lead internal and external audits and support regulatory inspections, manage communications regarding returned product analysis, lead cross-functional teams for product quality and distribution compliance, implement and improve quality processes and procedures, track departmental goals and performance indicators, identify and communicate quality/compliance risks, manage external contract design and manufacturing organizations
Seniority
Senior, hands-on IC with cross-functional influence