Quality Operation Supervisor
Core
Lead Quality Team Leads and Inspectors to manage inspection, lot qualification, non-conformance investigations, and lot release for medical device products.
Role type
Quality Operation Supervisor
Builds
Medical device products (specifically Omnipod platform)
Domain
Medical Devices / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO13485, GDP, GLP, root-cause analysis, failure analysis, calibration management, MES/SAP, PDM quality operations, non-conformance management, test method development
Preferred skills
Engineering or Science degree, medical device industry experience
Technologies
MES, SAP, PDM
Responsibilities
Provide leadership to team members including training support; manage IPQA activities and oversee nonconformances investigation; manage pre- and post-sterile Lot Qual lab and oversee lot failure investigation; oversee IPQA and Lot Qualification personnel to ensure adequate staffing; manage MES/SAP Lot release; support Quality and lot release team with MES/SAP issues; provide support for PQ builds and new projects; work with Quality Engineers on test method development; manage process for handling non-conforming materials; assist in root-cause investigations; review DHR documentation; manage continuous improvement projects; monitor calibration activities; manage PDM quality operation; approve/sign-off work of Quality Inspectors and support quality audits
Seniority
Mid-level, hands-on IC