Quality Systems Manager - Plymouth, MN
Core
Lead the Quality Management System (QMS) for a high-volume medical device manufacturing site, ensuring compliance with regulations and driving continuous improvement in quality processes.
Role type
Senior IC Quality Systems Manager
Builds
Compliant, effective quality systems for Peripheral Vascular Health medical devices
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS process leadership, regulatory compliance interpretation, audit management, CAPA management, document control, cross-functional collaboration, stakeholder influence, continuous improvement, metrics reporting
Preferred skills
Engineering or Life Sciences degree, FDA/ISO 13485/MDSAP audit experience, regulated industry experience, project leadership, ASQ certification
Technologies
QMS software, document control systems, audit management tools
Responsibilities
Oversee development and maintenance of quality programs and procedures; Provide expertise in interpreting regulatory and internal policies; Conduct process analyses to enforce requirements; Lead audit and inspection preparation and resolution; Prepare reports and documentation such as CAPA; Coordinate legal requests for government investigations; Ensure quality assurance programs are maintained and modified; Facilitate uniform standards and best practice sharing globally
Seniority
Senior, hands-on IC
