Tasks & Responsibilities:
* Responsible for the annual supplier audit schedule
* Planning, preparation and auditing suppliers as Lead Auditor
* Participation in the selcetion, evaluation, monitoring and development of suppliers
* Cooperation with suppliers on quality related topics (e.g., in case of external audits)
* Support in the CSV process from quality perspective
* Assistance with the Design Change Control and Design Control process
* Performance of internal audits (Internal Auditor)
* Preparation and support of external audits (notified bodies, authorities, customers)
* Continous contribution on process improvement and aligment with other Critical Care site
* Provision and reporting of monthly KPIs
* Maintenance, review and approval of QMS related documentation and record
* Collaboration in internal quality projects
Required Profile:
* Degree in medical technology, engineering, science or similar relevant education
* Minimum 3 years of hands-on expierence in Quality and Environmental Management ISO13485
* At least 2 year experience as Lead Auditor in supplier audits
* Background in close collaboration with R&D projects and CSV processes
* Relevant knowledge for implementation and usage of applicable standars and regulations
* Proven external and/or internal trainings in QM / ISO13485 / FDA / EU MDR
* Ideally trained as an Internal Auditor
* Demonstrated history in Quality/Environmental related projectes (e.g., CAPAs, EU MDR uplift) are an advantage
* Written and spoken fluency in English and German
* On-site work for at least 1-2 days per week is expected; readiness to travel (25%)
We offer:
* High quality products in a life-saving environment
* Attractive conditions, 30 paid vacation days per year
* Possibility of mobile working
* Modern workplace equipment
* Business Bike and corporate benefits
* Career opportunities in a well-known company
* Individual trainings