Director of Quality Operations (m/f/d)
- Jotec GmbH Jobportal
- Hechingen
- Qualitätsmanagement, Qualitätssicherung
- Publiziert: 15.04.2025
We are hiring a
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
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com