Director of Quality Operations (m/f/d)

IT-Systemhaus der Bundesagentur für Arbeit; Stein; Hybrid; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A global leader in medical manufacturing is seeking a Director of Quality Operations in Stein, Germany. This role requires over 10 years of quality management experience within the medical industry, focusing on compliance with FDA standards and ISO 13485. The ideal candidate will lead quality control and laboratory operations while fostering a culture of quality awareness. The company offers various benefits such as hybrid working, a business bike, and a company pension.

Leistungen

Hybrid working

Business bike

Company pension

Subsidy for canteen

Qualifikationen

• 10+ years of experience in quality management in a manufacturing organization.
• Extensive knowledge of FDA regulations and ISO 13485.
• Experience in managing audits and regulatory inspections.

Aufgaben

• Oversee manufacturing control and quality laboratory operations.
• Release products to the markets.
• Lead change control for sustaining business.

Kenntnisse

Quality management experience

Knowledge of FDA regulations

Leadership in quality control

Analytical and problem-solving skills

Communication skills

Jobbeschreibung

Stellendetails zu: Director of Quality Operations (m/f/d)

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)

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, 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