Quality Manager / Senior Quality Manager (m/w/d)
Core
Managing and developing quality management systems for medical devices and cosmetics, ensuring compliance with ISO 13485 and ISO 22716 standards.
Role type
Senior Quality Manager
Builds
Quality management systems and documentation for regulated product groups
Domain
Medical devices and cosmetics
Required skills
Quality management systems (ISO 13485, ISO 22716), regulatory requirements, technical documentation, audit planning and execution, corrective and preventive action management, stakeholder coordination, project management
Preferred skills
Process management, English language proficiency
Technologies
ISO 13485, ISO 22716
Responsibilities
Develop and maintain quality management systems, create and review quality documents, analyze processes for improvement, plan and conduct internal and external audits, coordinate quality issues with internal teams and external partners, support regulatory questions for medical devices, document and resolve quality complaints
Seniority
Senior, hands-on IC