Quality Assurance Specialist (m/w/d)
Core
Ensuring product quality and compliance with ISO 13485 standards across the production and supply chain for medical and bioprocess technology components.
Role type
Quality Assurance Specialist
Builds
Medical and bioprocess technology components for cardiac, vascular, transplant surgery, dialysis, and life-support applications
Domain
Medical technology / Bioprocess engineering
Required skills
ISO 13485 compliance, CAPA management, supplier qualification and auditing, material compliance documentation, ERP systems (Microsoft Dynamics Navision), technical drawing interpretation, process validation planning
Preferred skills
Technical degree in electrical engineering, medical technology, or mechatronics, experience with flexible hose systems
Technologies
Microsoft Dynamics Navision, MS Office
Responsibilities
Implement and develop quality assurance specifications including test and goods receipt protocols, conduct and document process and quality controls in all production areas, coordinate CAPA processes, support internal and external audits, manage supplier qualification and auditing
Seniority
Senior, hands-on IC