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