Design Quality Engineer I (m/f/d)
- Jotec GmbH Jobportal
- Hechingen
- Qualitätsmanagement, Qualitätssicherung
- Publiziert: 09.04.2025
We are hiring a
Your Strength
- Minimum of a Bachelor’s Degree in an Engineering or science field, or equivalent work experience
- Minimum of 2 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
- Support the execution of design verification / validation protocols to demonstrate the design output fulfills the design input requirements
- Provide hands on support to validate test methods
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
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com