Senior Specialist QA & PMS
Core
Execute Quality Assurance and Post Market Surveillance activities to ensure regulatory compliance and manage product safety reporting for medical devices/healthcare products.
Role type
Specialist QA & PMS
Builds
Quality Management Systems (QMS) and compliance frameworks
Domain
Healthcare / Medical Devices / Regulatory Affairs
Required skills
Quality Management Systems knowledge, regulatory compliance principles, product safety reporting, non-conformance management, CAPA management, SOP development, audit participation, quality metrics analysis
Preferred skills
Medical device/pharmaceutical industry experience, complaint handling processes, ISO 13485, MDR, SFDA requirements
Technologies
Microsoft Office
Responsibilities
Execute QA and PMS activities per local/regional/corporate procedures; Support QMS implementation and maintenance; Coordinate product safety reporting with stakeholders; Manage quality events including NCs and CAPAs; Develop and update quality procedures and SOPs; Participate in internal/external audits; Deliver quality and compliance training; Collaborate with EEMEA and global RAQA teams; Monitor and report QA/PMS metrics.
Seniority
Junior to Mid-level, hands-on IC