Design Quality Engineer III (m/f/d)

  • Jotec GmbH Jobportal
  • Hechingen
  • Publiziert: 28.03.2025
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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 III (m/f/d)

Your Strength

  • Minimum of a Bachelor’s Degree in an Engineering or science field, or equivalent work experience
  • Minimum of 5 years 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
  • Proven experience in design controls and risk management, from design concept to commercialization
  • Good knowledge of application of statistical methods and acceptance sampling within a regulated industry such as medical device manufacturing or pharmaceutical
  • Specific experience in designing, preparing, executing, and statistically analyzing validations, as well as developing report packages, to approve equipment, processes, and software

Your Contribution

  • Provide Design Quality (Design Assurance) Engineering project leadership to ensure the successful development and commercial launch of new products
  • Develop design control tools for global application of harmonized design control processes
  • Create Validation Master Plans and Validation Project Plans 
  • Establish, review, and approve design input requirements as appropriate
  • Develop, conduct, and document qualifications / validations 
  • Develop, review and approve risk management documents, including plans, reports, and FMEAs
  • Ensure that the company complies with all applicable federal, industry, and corporate procedures, guidelines, and regulations to optain global regulatory approvals
  • Interface with multiple manufacturing facilities

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 you! 
 
Maximiljane Tyrs, jobs.europe@artivion.com, T: 07471 922 352
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com