Beschreibung
For one of our medical devices clients we are seeking freelance support as:Quality manager with focus on change management (M/F/D)
Tasks:
· Quality management in accordance to ISO 13485
· Managing the subjects of quality in compliance with regulatory requirements
· Initiation, implementation and updating of quality procedures and quality manual
· Managing the compliance training processes
· PRRC for GmbH manufacturing according to the new MDR (person responsible regulatory compliance)
· QA leader – manage internal and external audits
Qualification:
· knowledge in the medical device industry, experience of 5 years in quality positions. Experience in working at an ISO 13485 regulation environment
· BSc/MSc in Life science/Bio Medical/Electronics/ Machine Engineer or other Quality relevant degree
· Experience in leading cross-functional project teams
· Professional experience RA or in quality management system relating to medical device field (At least 4 years)
· Demonstrated leadership skills without direct authority responsibility
· Nice Have: Certification as an auditor
· Must Have: Business fluency in English
Requirements:
· Start: asap
· Duration: 12 months
· Capacity: full-time