Quality Management Engineer, Supplier Auditor (m/f/d)
PULSION Medical Systems SE - GETINGE Group (Job via XING.com)
📍 München
📑 Permanent contract
⏱ Full time
📐 Engineering
💼 Professional
Tasks
- Responsible for the annual supplier audit schedule
- Planning, preparation and auditing suppliers as Lead Auditor
- Participation in the selection, 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)
- Continuous contribution on process improvement and alignment with other Critical Care site
- Provision and reporting of monthly KPIs
- Maintenance, review and approval of QMS related documentation and records
- Collaboration in internal quality projects
Hard skills
- Degree in medical technology, engineering, science or similar relevant education
- Minimum 3 years of hands-on experience in Quality and Environmental Management ISO13485
- At least 2 years 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 standards 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 projects (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%)
Benefits
- 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
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