Manager Quality & Regulatory Affairs (f/m/d)

Freudenberg; Weinheim (Kernstadt); Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

Une entreprise leader dans le secteur des matériaux de performance recherche un spécialiste en gestion de la qualité. Vous serez en charge du développement et de la maintenance du système de qualité, ainsi que de la gestion des audits et des conformance réglementaire. Si vous êtes une personne avec un bon esprit d'équipe, une forte expérience technique et une maîtrise des normes ISO, rejoignez-nous pour faire la différence!

Qualifikationen

• Diplôme dans un domaine technique lié à la qualité.
• Expérience en gestion de la qualité, notamment avec ISO 13485 et MDR.
• Bilingue en allemand et en anglais.

Aufgaben

• Maintenir et développer le système de gestion de la qualité.
• Planifier et exécuter des audits internes et externes.
• Gestion des affaires réglementaires et soutien aux partenaires externes.

Kenntnisse

Gestion de la qualité

Compétences en résolution de problèmes

Travail en équipe

Compétences en communication

Connaissance des normes ISO

Maîtrise de l'allemand

Maîtrise de l'anglais

Utilisation de MS Office

Ausbildung

Diplôme en technologie médicale, gestion de la qualité, ingénierie

Tools

Logiciels QMS

Jobbeschreibung

Working at Freudenberg: We will wow your world!

Responsibilities:

1. Maintenance and further development of our quality management system in compliance with all relevant legal and normative requirements (ISO 13485, MDR, FDA, and specific customer requirements).

2. Planning, coordination, and execution of internal and external audits and certifications, including the coordination of corrective and preventive actions (CAPA).

3. Carrying out risk analyses according to ISO 14971 in the team as FMEA moderator.

4. Processing of regulatory affairs and product stewardship for the products of the Healthcare Division of Freudenberg Performance Materials.

5. Quality-related support of change processes and the implementation of process optimizations, including any necessary qualification/validation activities, also as validation manager.

6. Preparation and execution of training courses to ensure and raise awareness of quality and hygiene-related topics.

7. Collaboration in national and international projects to ensure quality standards.

8. Quality-related support and safeguarding of business relationships with external partners such as customers, suppliers, and service providers.

9. Maintaining quality-related documentation and supporting the creation of quality reports and KPIs.

Qualifications:

1. Completed studies in the field of medical technology, quality management, engineering, or a comparable qualification.

2. First experience in quality management, especially in ISO 13485, MDR, FDA, ISO 14971, and validation activities.

3. Initial experience with internal and external audits and dealing with authorities is desirable.

4. Structured, solution-oriented way of working with high problem-solving skills.

5. Convincing and assertive personality with strong teamwork skills.

6. Very good written and spoken German and English skills.

7. Confident handling of MS Office and QMS software.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Performance Materials GmbH & Co. KG