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

Remotely; Hechingen; Hybrid; EUR 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Hybrid working

Company pension

Subsidy for canteen

Zusammenfassung

Artivion is seeking a Director of Quality Operations (m/f/d) with a strong background in quality management within medical manufacturing. The role is hybrid, emphasizing leadership of quality control and engineering functions to ensure compliance with FDA, ISO 13485, MDR, and related standards.

You will oversee manufacturing quality, process validation, audits, and change control, while driving continuous improvements and mentoring the sustain quality team.

Qualifikationen

• 10+ years of quality management experience in a manufacturing organization (medical)
• Focus 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

Aufgaben

• 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

Kenntnisse

Quality management

Quality operations

Regulatory knowledge

Leadership

Analytical skills

Communication

Audits & inspections

Process improvement

Team leadership

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 a

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 pension and subsidy for our canteen