Director of Quality Operations (m/f/d)

JOTEC GmbH 2016; Hechingen; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Join a forward-thinking company dedicated to saving lives through high-quality medical products. As the Director of Quality Operations, you will play a crucial role in ensuring compliance with industry standards and leading a team committed to excellence. This position offers an independent area of responsibility and the chance to make a significant impact on product quality and regulatory compliance. With an exciting field of activity in a global team, you will also benefit from extensive training and various perks, including hybrid working options and a company pension plan. If you're ready to contribute your expertise and grow with us, we invite you to apply.

Leistungen

Hybrid working

Business bike

Company pension

Subsidy for canteen

Qualifikationen

• 10+ years of experience in quality management in the medical industry.
• Extensive knowledge of FDA regulations and ISO 13485 standards.

Aufgaben

• Oversee quality control and ensure compliance with FDA and ISO regulations.
• Lead qualification of equipment and manage change control activities.
• Develop and mentor the quality team for operational excellence.

Kenntnisse

Quality Management

FDA Regulations

ISO 13485

Leadership

Analytical Skills

Problem-Solving

Communication Skills

Interpersonal Skills

Ausbildung

Bachelor's Degree in a relevant field

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 aDirector of Quality Operations (m/f/d)

Your Strength

• 10+ years of experience in quality management in a manufacturing organization within the medical industry
• Extensive knowledge of FDA regulations, ISO 13485, and other relevant quality standards
• Proven leadership experience in quality control, manufacturing quality, supplier quality, and process validation
• Strong analytical, problem-solving, and decision-making abilities
• Excellent communication, interpersonal, and team leadership skills
• Experience in managing audits, regulatory inspections, and compliance initiatives

Your Contribution

• Oversee manufacturing control, quality control, and quality control laboratory operations to ensure compliance with FDA, ISO, and other applicable regulations
• Release of products to the markets
• Lead qualification of equipment, verification and validation of processes, and change control activities
• Ensure robust product lifecycle management
• Establish and monitor key performance indicators
• Lead change control for sustaining business
• Develop and mentor the sustain quality team, fostering a culture of quality awareness and operational excellence
• Collaborate cross-functionally
• Serve as the primary point of contact for quality-related communications with internal stakeholders, regulatory authorities, and external customers

Our Strength

• An exciting field of activity in a global team
• An independent area of responsibility
• Intensive training with mentoring program
• Various benefits such as hybrid working, business bike, company pension and subsidy for our canteen

Contact

Apply now and join the Artivion team. We are looking forward to receiving your application documents directly via our online system.Maximiljane Tyrs, T: 07471 922 352
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com