It's a good feeling to know you're doing your best with purpose every day.
At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Together with surgeons worldwide, we save lives. In doing so, we rely on the strengths of each and every employee. Your strength counts, too: As an important link in the chain, you make a contribution to saving lives together with us. Contribute your strengths and let us grow together.

We are hiring

Supplier Quality Engineer (m/f/d) - Hechingen, Germany

Your Strength

  • Completed scientific or technical/medical studies with at least 2 years of professional experience in Quality Management or completed scientific or technical/medical education with at least 4 years of professional experience in Quality Management
  • Experience in Quality Management Systems (ISO 13485)
  • Experience in supplier management and first article inspections
  • Qualification as an auditor for supplier audits according to ISO 13485 and ISO 9001
  • Analytical, methodical, and critical mindset
  • Strong written and verbal communication skills
  • Good documentation skills for complex tasks
  • Strong coordination skills
  • Structured, conscientious, and reliable way of working
  • High attention to detail and willingness to learn

Your Contribution

  • Maintenance, preservation, and improvement of the supplier master file
  • Preservation and continuous improvement of the supplier qualification and evaluation process
  • Coordination of all activities related to supplier qualification and evaluation
  • Maintenance of the list of approved suppliers and service providers
  • Review of supplier documentation for completeness and traceability
  • Comparison of supplier specifications with internal specifications
  • Review of criticality assessments and approval of suppliers for criticality classes 1 and 2
  • Coordination and contribution to the creation of Quality Assurance Agreements (QAA)
  • Preparation, support, and follow-up of supplier audits
  • Support of CAPA measures, nonconformity reports, and resulting change requests
  • Monthly review of supplier certificates and request updated certificates if required
  • Participation in NC boards and change boards, including coordination and documentation
  • Coordination, planning, execution, and documentation of first article inspections
  • Verification of first article characteristics (dimensions, surface roughness, materials, etc.) according to drawings
  • Review and evaluation of externally performed first article inspections
  • Planning of incoming goods inspection steps in cooperation with QC

Our Strength

  • An international team with a strong focus on quality, innovation, and collaborationA role with high responsibility in ensuring product and process safety
  • Flexible working conditions and attractive benefits, including company pension scheme and EGYM Wellpass
  • Cross-functional collaboration with R&D, QA, QC, Purchasing, and Production
  • Professional development opportunities in a regulated medical device environment
  • A clear mission: saving lives through quality and excellence

Contact

Apply now and join the Artivion team. We are looking forward to receiving your application documents directly via our online system.

Brian Russo - T: +41 435 08 39 01
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.
www.artivion.com

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