25 km
PULSION Medical Systems SE - GETINGE Group
Quality Management Engineer­­,­­ Supplier Auditor (m­­/­­f­­/­­d) 03.02.2025 PULSION Medical Systems SE - GETINGE Group München
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Quality Management Engineer, Supplier Auditor (m/f/d)
München
Aktualität: 03.02.2025

Anzeigeninhalt:

03.02.2025, PULSION Medical Systems SE - GETINGE Group
München
Quality Management Engineer, Supplier Auditor (m/f/d)
Aufgaben:
We are currently looking for an experienced Quality Management Engineer, Supplier Auditor to join our Quality department in Feldkirchen, Germany, part of the product area Critical Care at Getinge. This role will support the organization as Supplier Auditor, will closely collaborate with our R&D department to assist with their projects, will work on our CSV process, and conitonously improve our quality management system. 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
Qualifikationen:
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%)

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