Director Quality System / Quality Excellence EMEA (m/f/d)

  • Jotec GmbH Jobportal
  • Hechingen
  • Qualitätsmanagement, Qualitätssicherung
  • Publiziert: 15.04.2025
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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
 
Director Quality System / Quality Excellence EMEA  (m/f/d)

Your Strength

  • 10+ years of experience in medical device quality management, with at least 5 years in a leadership role
  • In-depth understanding of ISO 13485, FDA QSR, MDR, IVDR, and other relevant standards/regulations
  • Proven ability to lead and develop high-performing quality teams
  • Strong analytical and problem-Solving skills, with experience in root cause analysis, CAPA, and risk management
  • Proven experience in project management 
  • Familiar with QMS software, e-QMS tools, data analytics, and industry best practices
  • Excellent communication and stakeholder management skills

Your Contribution

  • Develop, Implement, and maintain a world-class Quality Management System that ensures compliance with global regulatory requirements (e.g. FDA, ISO 13485, MDR)
  • Oversee document control, audits, complaints, vigilance, post-market-surveillance, risk management, CAPA, training, and quality metrics
  • Ensure seamless integration of quality processes with business objectives
  • Drive training and competency programs for the Quality and Regulatory teams
  • Lead a team of quality professionals, fostering a culture of quality excellence across the organizations

Our Strength

  • An exciting field of activity in a global team 
  • An independent area of responsibility 
  • Intensive training with mentoring program 
  • Various benefits such as hybrid working, business bike, company pension and 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