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

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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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