Design Quality Engineer II (m/w/d)

Your strength:

• Minimum of a Bachelor's Degree in an Engineering or science field, or equivalent work experience
• 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
• A goal-oriented team player, open-minded, flexible, and able to adapt easily and accept new ideas quickly
• You are a self-starter, alert for situations requiring action, confident of being able to think situations through, and possess the ability to work independently with minimal supervision
• Able to travel <25%; Able to travel internationally

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
• Review and approve design input requirements as appropriate
• Review and approve the translation of design input requirements into design output documents
• Establish and/or maintain Risk Management Files to support product lines and corporate projects
• Review and approve design verification / validation protocols and reports that demonstrate the design output fulfills the design input requirements
• Review, approve, and validate Test Methods
• Conduct investigations, documentation, review, and approval of non-conformances, CAPA's and customer complaints as necessary

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 mobile working, bike leasing and company pension

Apply now and join the Artivion team. We are looking forward to you! 

Irmtraud Kögel, jobs.europe@artivion.com, T: 07471 922 349
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com