Director Quality System / Quality Excellence EMEA (m/f/d) (Qualitätsmanager/in)

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 Quality System / Quality Excellence EMEA (m/f/d)

Your Strength

- 10+ years of experience in medical device quality management, with at least 5 years in a leadership role
- In-depth understanding of ISO 13485, FDA QSR, MDR, IVDR, and other relevant standards/regulations
- Proven ability to lead and develop high-performing quality teams
- Strong analytical and problem-Solving skills, with experience in root cause analysis, CAPA, and risk management
- Proven experience in project management
- Familiar with QMS software, e-QMS tools, data analytics, and industry best practices
- Excellent communication and stakeholder management skills

Your Contribution

- Develop, Implement, and maintain a world-class Quality Management System that ensures compliance with global regulatory requirements (e.g. FDA, ISO 13485, MDR)
- Oversee document control, audits, complaints, vigilance, post-market-surveillance, risk management, CAPA, training, and quality metrics
- Ensure seamless integration of quality processes with business objectives
- Drive training and competency programs for the Quality and Regulatory teams
- Lead a team of quality professionals, fostering a culture of quality excellence across the organizations

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

Apply now and join the Artivion team. We look forward to hearing from you!

Maximiljane Tyrs, [email protected] (https://mailto:[email protected]) , T: 07471 922 352
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com (http://www.artivion.com/)

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
- 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

Apply now and join the Artivion team. We look forward to hearing from you!

Maximiljane Tyrs, [email protected] (https://mailto:[email protected]) , T: 07471 922 352
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,
Lotzenäcker 23, 72379 Hechingen
www.artivion.com (http://www.artivion.com/)

Es ist ein gutes Gefühl zu wissen, wofür Du täglich Dein Bestes gibst. Bei Artivion stellen wir hochwertige Produkte und Lösungen zur Behandlung von Aortenerkrankungen her. Gemeinsam mit Chirurgen weltweit retten wir Leben. Dabei setzen wir auf die Stärken jedes einzelnen Mitarbeiters. Auch Deine Stärke zählt: Als wichtiges Glied in der Kette leistest Du gemeinsam mit uns einen Beitrag, Leben zu retten. Bringe Deine Stärken ein und lass uns gemeinsam wachsen.

Wir suchen einen

MITARBEITER QUALITÄTSMANAGEMENT / CAPA / LIEFERANTENMANAGEMENT m/w/d
Deine Stärke:

* Abgeschlossenes ingenieur- oder naturwissenschaftliches Studium oder vergleichbare Fachrichtung bzw. entsprechende Ausbildung
* Berufserfahrung im Qualitätsmanagement gemäß ISO 13485 wünschenswert
* Sicherer Umgang mit MS Office
* Gute Englischkenntnisse

Dein Beitrag:
* Koordinieren und Verantworten von CAPA-Aktivitäten und -Gremien
* Erarbeiten, Durchführen und Überwachen von Korrektur- und Vorbeugungsmaßnahmen innerhalb des Change-Management-Prozesses
* Initiieren von CAPA-Starts anhand diverser QMH-Prozesse
* Durchführen von Ursachenanalysen bei Produkt- und Prozessbeanstandungen in Zusammenarbeit mit den entsprechenden Fachabteilungen
* Durchführen von Wirksamkeitsprüfungen
* Initiieren, Bearbeiten und Überwachen von Nonconformities
* Vorbereiten, Durchführen und Nachbereiten von Lieferanten-Bewertungen und -?Audits
* Erstellen von Berichten und Unterlagen für Audits
* Pflege der Lieferanten-Masterfiles
* Mitarbeiten bei der Aufrechterhaltung, Überwachung und Weiterentwicklung des Qualitätsmanagementsystems

Unsere Stärke:
* Anspruchsvolle und abwechslungsreiche Aufgaben
* Intensive Einarbeitung mit Mentorenprogramm
* Vielfältige Benefits wie mobiles Arbeiten und Gleitzeitregelung, Fahrrad-Leasing, betriebliche Altersvorsorge und vermögenswirksame Leistungen
* Ein erfolgreiches Medizintechnik-Unternehmen mit großem Campus und moderner Ausstattung



Bewirb Dich jetzt und komm ins Artivion-Team. Wir freuen uns auf Dich!

Daniel Weber, [email protected], T +49 (0)7471 922 353
JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.
Lotzenäcker 23, 72379 Hechingen, www.artivion.com