Global QA Senior Manager, Medical Devices & Drug/Device Combined Products
Core
Lead global Quality Assurance projects for medical devices and drug/device combination products, ensuring compliance with international standards and supporting manufacturing sites.
Role type
Senior Manager, Global Quality Assurance (Medical Devices)
Builds
Quality Management Systems (QMS) and compliant medical device products
Domain
Pharmaceutical and Medical Device Industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485, MDSAP, MDR, 21 CFR part 4, 21 CFR part 820, Design Control, Project Management, Vendor Assessment, Audit Leadership, CAPA management, Change Request management
Preferred skills
Master's degree in pharmacy, chemistry, or biology
Technologies
None stated
Responsibilities
Contribute to QMS improvements for medical devices and combination products; Own key Medical Devices Process/SOPs; Ensure corporate QMS implementation at manufacturing sites; Support manufacturing sites with guidance on complaints, deviations, and audits; Lead assigned GQA projects and audits
Seniority
Senior, hands-on IC
