Design Quality Engineer II (m/f/d)

ZipRecruiter; Hechingen; Hybrid; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Design Quality Engineer II to enhance product development and ensure compliance with quality standards. This role involves collaborating with R&D teams, managing design controls, and validating processes in a dynamic environment. You will play a crucial part in the lifecycle of medical devices, ensuring they meet rigorous regulatory standards. The company offers a supportive atmosphere with opportunities for professional growth, including training and mentoring programs. If you are a goal-oriented team player with a passion for quality engineering, this is the perfect opportunity for you.

Leistungen

Hybrid Working

Business Bike

Company Pension

Canteen Subsidy

Intensive Training Program

Qualifikationen

• Several years of hands-on experience in FDA/MDR regulatory industry.
• Specific experience in medical device design controls and validations.

Aufgaben

• Support the development and launch of new products with R&D teams.
• Review and approve design input and output documents.
• Conduct investigations and approve non-conformances as needed.

Kenntnisse

Design Controls

Risk Management

Validation Analysis

Problem-Solving

Team Collaboration

Adaptability

Ausbildung

Bachelor's Degree in Engineering or Science

Tools

ISO Standards

FDA Regulations

Quality System Regulations

Jobbeschreibung

Job Description

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

Responsibilities:

• Partner with R&D and other cross-functional groups to support the 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, CAPAs and customer complaints as necessary.

Minimum Qualifications:

• Minimum of a Bachelor's Degree in an engineering or science field, or equivalent work experience.
• Several years of hands-on experience; preferably in an 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 with an open mind and a high level of adaptability, eager to embrace new ideas quickly.
• Ability to work independently with minimal supervision.

What We Offer:

• An exciting field of activity.
• An autonomous area of responsibility.
• Active participation in an inter quality team.
• Intensive training with mentoring program.
• Diverse benefits such as hybrid working, business bike, company pension and subsidy for our canteen.

JBRP1_DE