Design Quality Engineer II (m/f/d)

• Jotec GmbH Jobportal
• Hechingen
• Qualitätsmanagement, Qualitätssicherung
• Publiziert: 09.04.2025
  
  

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 a Design Quality Engineer II (m/f/d)

Your Strength

• Minimum of a Bachelor’s Degree in an Engineering or science field, or equivalent work experience
• Minimum of 3 Hands-on experience; preferably in a FDA / MDR regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards
• Specific experience in medical device Design Controls for developing and preparing design specifications and effectively demonstrating that the design output fulfills the design input
• Specific experience designing, preparing, executing, and statistically analyzing validations, as well as developing report packages, to approve equipment, processes, methods and software
• Goal-oriented team player, open-minded, and able to adapt easily and accept new ideas quickly
• Ability to work independently with minimal supervision
  
  

Your Contribution

• Partner with R&D and other cross functional groups to support successful development and commercial launch of new products
• Partner with R&D and other cross functional groups to support the proper application of design controls, process validation, risk management, and the investigation/correction of design failures/challenges
• Review and approve design input requirements as appropriate
• Review and approve the translation of design input requirements into design output documents
• Establish and/or maintain Risk Management Files to support product lines and corporate projects
• Review and approve design verification / validation protocols and reports that demonstrate the design output fulfills the design input requirements
• Review, approve, and validate Test Methods
• Conduct investigations, documentation, review, and approval of non-conformances, CAPA’s and customer complaints as necessary
  
  

Our Strength

• An exciting field of activity
• An autonomous area of responsibility
• Active participation in an international Quality Team
• Intensive training with mentoring program
• Diverse benefits such as hybrid working, business bike, company pension & subsidy for our canteen
  
  

Contact

Apply now and join the Artivion team. We are looking forward to receiving your application documents directly via our online system. Maximiljane Tyrs, T: 07471 922 352

JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,

Lotzenäcker 23, 72379 Hechingen

www.artivion.com

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