Operations Quality Shift Lead
Core
General supervision of manufacturing inspection and test functions at every stage of the manufacturing process, including function failure testing and physical defects.
Role type
Operations Quality Shift Lead
Builds
Diabetes Care products (e.g., FreeStyle Libre 3) and other medical devices
Domain
Healthcare / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality assurance strategy implementation, risk assessment, team supervision, audit facilitation, vendor liaison, continuous improvement, risk management tools, cross-functional collaboration, health and safety management, quality/compliance decision making, audit readiness, quality system enhancement
Preferred skills
Yellow belt certification
Technologies
GMP, GDP, ISO13485, Quality Management System (QMS)
Responsibilities
Oversee operational implementation of quality assurance strategies and regulations; supervise inspection and test activities of operators; complete assessment of potential risks and ensure compliance; supervise team to ensure quality control aspects are met; facilitate audits and regulatory inspections; lead a team of Operations Quality engineers; manage functional area compliance to policies; lead continuous improvement and maintenance of the QMS; act as Subject Matter Expert in risk management tools; build cross-functional relationships with R&D, Technical, Engineering, Operations, and Regulatory Affairs; manage team Health and Safety; lead monitoring and compliance of the QMS; lead team in making Quality/Compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging; lead audit readiness; identify and lead projects to enhance quality system effectiveness; champion a "right first time" approach to Quality Records
Seniority
Mid-level, hands-on IC with people management responsibilities