Qualitätsmanagementmitarbeiter (m/w/d)
Core
Creating, reviewing, and auditing quality documentation and standard operating procedures (SOPs) for a medical device company.
Role type
Quality Management Specialist (ISO 13485)
Builds
Quality management systems and regulatory documentation
Domain
Medical devices / Quality Assurance
Required skills
Change control management, ISO 13485 audit preparation, SOP creation, stakeholder agreement management, scientific background
Preferred skills
GMP guidelines experience, English fluency, IT proficiency
Technologies
ISO 13485, GMP
Responsibilities
Create and review quality documentation and SOPs, coordinate change control processes, manage quality agreements with partners, plan and prepare ISO 13485 audits
Seniority
Mid-level, specialized IC