QA Operations Expert
Core
Manage quality aspects for new autoinjector device introductions and oversee primary packaging/device suppliers to ensure cGMP compliance.
Role type
Senior QA Operations Expert (Medical Devices)
Builds
Commercial medical devices and combination products
Domain
Healthcare / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier Quality Management, cGMP compliance, Data Integrity, Change Management, Document Review (DHF/DMR), Exception Investigation, Adverse Event Reporting, Operational Excellence
Preferred skills
Global collaboration, Negotiation
Technologies
QMS, SPC
Responsibilities
Manage third-party management of device component and primary packaging material suppliers; Evaluate and implement changes related to assigned materials; Oversee incoming testing activities ensuring compliance with cGxP; Review and approve production, QC, and AS&T records; Support exception investigations; Review and approve DHF and DMR documents; Report technical complaints/adverse events within 24 hours; Support OpEx improvement projects.
Seniority
Senior, hands-on IC