Design Quality Engineer II (m/f/d)

JOTEC GmbH 2016; Hechingen; Hybrid; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Design Quality Engineer II to enhance product quality and compliance in medical device design. This role involves collaborating with R&D teams to ensure successful product launches while adhering to stringent regulatory standards. You will be responsible for reviewing design specifications, conducting validations, and managing risk assessments. This position offers a unique opportunity to contribute to life-saving innovations in a dynamic environment. Join a supportive team that values your expertise and fosters professional growth through mentoring and diverse benefits, including hybrid working options and a company pension plan.

Leistungen

Hybrid working

Business bike

Company pension

Subsidy for canteen

Qualifikationen

• 3+ years experience in FDA/MDR regulatory industry.
• In-depth knowledge of Good Manufacturing Practices and ISO Standards.

Aufgaben

• Partner with R&D for product development and launch.
• Review and approve design input and output documents.
• Conduct investigations of non-conformances and CAPA’s.

Kenntnisse

Design Controls

Good Manufacturing Practices

Quality System Regulations

ISO Standards

Statistical Analysis

Risk Management

Team Collaboration

Independent Work

Ausbildung

Bachelor’s Degree in Engineering or Science

Jobbeschreibung

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 Design Quality Engineer II (m/f/d).

Your Strength

• Minimum of a Bachelor’s Degree in an Engineering or science field, or equivalent work experience.
• Minimum of 3 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.
• 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.
• 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 hybrid working, business bike, company pension & subsidy for our canteen.

Contact

Apply now and join the Artivion team. We are looking forward to you!
Maximiljane Tyrs, [e-mail], T: 07471 922 352
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com