Director of Quality Operations (m/f/d) - Hybrid

Jotec GmbH; Stein; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Hybrid working

Company car

Company pension

Business bike

Zusammenfassung

JOTEC GmbH, a subsidiary of Artivion, Inc., is seeking a Director of Quality Operations to lead manufacturing quality control, quality engineering, and quality labs in a hybrid role. You will ensure compliance with FDA, ISO 13485, MDR, and related standards while guiding cross-functional teams to deliver safe, high-quality medical products.

You will develop KPI-driven strategies, oversee change control, and drive improvements across the quality organization, mentoring the sustain quality team.

Qualifikationen

• 10+ years of experience in quality management in a medical manufacturing environment.
• In-depth knowledge of FDA regulations, ISO 13485, MDR and related standards.
• Proven leadership in quality control, manufacturing quality and process validation.
• Strong communication, interpersonal and team leadership skills.
• Experience managing audits, regulatory inspections, and compliance initiatives.

Aufgaben

• Oversee manufacturing control, quality control, quality engineering, and quality lab operations to ensure compliance with FDA, ISO, MDR and other 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.
• Support change control for sustaining business.
• Drive problem solving, error proofing, and process improvements.
• Develop and mentor the sustain quality team, fostering quality culture.
• Collaborate cross-functionally with internal stakeholders, regulators, and customers.

Kenntnisse

Quality management

Manufacturing quality

FDA regulations

ISO 13485

Audits & inspections

Leadership

Process validation

Cross-functional collaboration

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.

Director of Quality Operations (m/f/d) - Hybrid

Your Strength

• 10+ years of experience in quality management in a manufacturing organization within the medical industry
• Focus of experience on Quality Operations/Manufacturing
• Extensive knowledge of FDA regulations, ISO 13485, and other relevant quality standards
• Proven leadership experience in quality control, manufacturing 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 in the Operations-Field
• Pragmatic, but compliant approach

Your Contribution

• Oversee manufacturing control, quality control, quality engineering, and quality laboratory operations to ensure compliance with FDA, ISO, MDR, 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
• Support change control for sustaining business
• Drive effective problem solving, error proofing, and process improvements
• Streamline quality processes to enable efficiencies and overall process effectiveness
• 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 car, company pension and subsidy for our canteen

Contact

Maximiljane Tyrs, T: 07471 922 352
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com