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)
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München
Quality Management Engineer, Supplier Auditor (m/f/d)
PULSION Medical Systems SE - GETINGE Group,
03.02.2025
München
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
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%)
Wir bieten:
- 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
Unser Kontakt:
We will be happy to answer any questions you may have.
Your contact person: Ms. Nicole Schmid
Get to know us in our company video .
PULSION Medical Systems SE | Human Resources | Hans-Riedl-Str. 21 | 85622 Feldkirchen
Jobs.pulsion@getinge.com | www.getinge.com/de/karriere
Www.getinge.com
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Informationen zur Anzeige:
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)
Über uns:
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
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%)
Wir bieten:
- 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
Unser Kontakt:
We will be happy to answer any questions you may have.
Your contact person: Ms. Nicole Schmid
Get to know us in our company video .
PULSION Medical Systems SE | Human Resources | Hans-Riedl-Str. 21 | 85622 Feldkirchen
Jobs.pulsion@getinge.com | www.getinge.com/de/karriere
Www.getinge.com
Berufsfeld
Technische Berufe, Ingenieurwesen
Fertigung, Inbetriebn., Qualitätsw.
Pharma, Chemie, Med., Biotechn.
Qualitätswesen, Prüfung
Qualitätswesen, Zulassung
Bundesland
Standorte