Quality Management Engineer, Supplier Auditor (m/f/d)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

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. 

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 

About us 

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.