Quality Specialist (m/w/d)
Core
Ensuring and continuously improving the quality management system and compliance with international quality and regulatory requirements for medical devices.
Role type
Quality Specialist (Medical Devices)
Builds
Quality management system compliance and regulatory adherence for medical device solutions.
Domain
Medical Devices / Healthcare
Required skills
ISO 13485, European Medical Device Regulation (MDR), Risk Analysis, CAPA Management, Change Control, Internal/External Audits, Documentation Management
Preferred skills
Medical Engineering, Natural Sciences, Engineering
Technologies
ISO 13485, MDR
Responsibilities
Maintain and optimize the quality management system according to ISO 13485; Handle and track deviations, CAPAs, and change requests; Plan and conduct internal and external audits; Collaborate with Development, Production, Regulatory Affairs, and Operations.
Seniority
Mid-level, hands-on specialist