We are hiring a
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
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com
