Job-Nr. 48644142

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

Jotec GmbH vor 4 Tagen

VollzeitHybrid

StandortHechingen, Baden-Württemberg

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.

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

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

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