Director of Quality Assurance

vor 4 Wochen


Bern, Schweiz ROCKEN Vollzeit

**Deine Verantwortung**:

- Sie leiten und führen personell den Bereich QM / RA mit drei Mitarbeitenden.
- Sie sind verantwortlich für die Leitung des Qualitätsmanagementsystems nach EN ISO 13485, MDR, FDA 820 und GMP.
- Im Rahmen der PRRC sind Sie zuständig für die Prüfung der Konformität der Medizinprodukte, die technische Dokumentation (auch deren Aktualität), Marktüberwachung und das Meldewesen.
- Sie stellen sicher, dass das Qualitätsmanagementsystem gemäß EN ISO 13485, MDR, FDA 820 und GMP, alle Medtech Prozesse gemäß den geltenden Anforderungen, die Wirksamkeit und Aufrechterhaltung des QMS sowie die Durchführung von Behörden
- und Zertifizierungsaudits gewährleistet sind.
- Sie setzen die operativen Ziele um unter Berücksichtigung der Termin-, Qualitäts
- und Kostenziele.

**Deine Skills**:

- Mindestens 5 Jahre Berufs
- und Führungserfahrung im Bereich Qualitätsmanagement der Medizintechnikbranche oder in einer ähnlichen Funktion
- Mehrere Jahre Berufserfahrung im Bereich Regulatory Affairs in der Medizintechnik branche von Vorteil
- Gute Kenntnisse der ISO 13485:2016 und der EU MDR 2017 / 745
- Erfahrungen im Projekt
- und Prozessmanagement und Auditieren
- Analytische und konzeptionelle Denkweise, selbständige und proaktive Arbeitsweise
- Sie kommunizieren fliessend in Deutsch und Englisch (schriftlich/mündlich)

**Benefits**:

- ** Gute Verkehrsanbindung und Erreichbarkeit**:

- ** Komfortables Büro mit moderner Infrastruktur**:

- ** Interessante und abwechslungsreiche Tätigkeiten/Projekte**:

- ** Eingespieltes und dynamisches Team**:

- **Flache Hierarchien**:

- ** Internationales Umfeld**:

- ** 13. Monatsgehalt**

**ROCKEN Jobs**:
**Profil erstellen**:
2 - 5 years



  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job Title: Senior Director, Quality Management for the Bern SiteWe are seeking a seasoned quality professional to lead our quality management efforts at our Bern site. As a Senior Director, Quality Management, you will be responsible for developing and implementing quality strategies that align with CSL's global quality standards.Key Responsibilities:Develop...


  • Bern, Schweiz Panda International Vollzeit

    **Director of Quality Management (QMS)**: **Location** - Bern, Switzerland **Business Sector** - Biotechnology **Job ref** - 22245 **Published** - 3 days ago Our client, a biotech company at the forefront of innovation, is seeking a Director of Quality Management to continue their growth trajectory in Switzerland. **Key Responsibilities**: - Develop...


  • Bern, Bern, Schweiz Consultys Vollzeit

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  • Bern, Bern, Schweiz CSL Vollzeit

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  • Bern, Bern, Schweiz Consultys Vollzeit

    Key Responsibilities:We are seeking a Quality Assurance Specialist to support the creation and implementation of aseptic operator training programs, procedures, and risk assessments. The ideal candidate will ensure adherence to global procedures and standards, creating SOPs for aseptic processing and training operators in microbiology, hygiene, and aseptic...


  • Bern, Schweiz Panda International Vollzeit

    **Quality Assurance Manager**: **Location** - Bern, Switzerland **Business Sector** - Pharmaceutical **Job ref** - 22249 **Published** - about 7 hours ago Our client, a renowned pharmaceutical company based in Switzerland, is seeking a highly skilled and experienced Quality Assurance Manager to lead and oversee the quality management functions within the...


  • Bern, Schweiz We make it GmbH Vollzeit

    We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest standards for...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at CSL Behring. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesQuality Assurance Systems ManagementYou will be responsible for maintaining and ensuring the effectiveness of our...


  • Bern, Bern, Schweiz Consultys Vollzeit

    Aseptic Processing and Quality Assurance ExpertWe are seeking an experienced Aseptic Processing and Quality Assurance Expert to support the creation and implementation of aseptic operator training programs, procedures, and risk assessments.Main Responsibilities:Creation and update of procedures and risk assessmentsEnsuring adherence to global procedures and...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at CSL Behring. As a Quality Assurance Specialist, you will be responsible for maintaining Quality Assurance Systems/Affiliate Quality Management System to ensure compliance with company standards and regulatory guidelines.Key ResponsibilitiesMaintain Quality Assurance...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at CSL Behring. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and processes.Key ResponsibilitiesQuality Assurance Systems ManagementYou will be responsible for maintaining and ensuring the...


  • Bern, Bern, Schweiz CSL Vollzeit

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at CSL Behring. As a key member of our quality assurance team, you will be responsible for ensuring compliance with company standards and regulatory guidelines.Key ResponsibilitiesMaintain Quality Assurance Systems/Affiliate Quality Management System to ensure compliance...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job Title: Senior Director, Quality Management for the Bern SiteWe are seeking a seasoned quality professional to lead our quality management efforts at our Bern site. As a Senior Director, Quality Management, you will be responsible for developing and implementing quality strategies that ensure the highest standards of quality and compliance in our...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job Title: Local Quality OfficerWe are seeking a highly skilled Local Quality Officer to join our team at CSL Behring. As a key member of our quality assurance team, you will be responsible for maintaining Quality Assurance Systems and ensuring compliance with company standards and regulatory guidelines.Key Responsibilities:Maintain Quality Assurance Systems...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job Title: Local Quality OfficerAbout the Role:We are seeking a highly skilled Local Quality Officer to join our team at CSL Behring. As a key member of our quality assurance team, you will be responsible for maintaining quality assurance systems and ensuring compliance with company standards and regulatory guidelines.Key Responsibilities:Develop and...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at CSL Behring. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and processes.Key ResponsibilitiesDevelop and implement quality assurance systems to ensure compliance with company standards and...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job Title: Local Quality OfficerCSL Behring is seeking a highly skilled Local Quality Officer to join our team. As a key member of our quality assurance team, you will be responsible for maintaining Quality Assurance Systems and ensuring compliance with company standards and regulatory guidelines.Key Responsibilities:Maintain Quality Assurance Systems to...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job Title: Local Quality OfficerCSL Behring is seeking a highly skilled Local Quality Officer to join our team. As a key member of our quality assurance team, you will be responsible for maintaining Quality Assurance Systems/Affiliate Quality Management System to ensure compliance with company standards and regulatory guidelines.Key Responsibilities:Develop...


  • Bern, Bern, Schweiz Cisco Vollzeit

    Cisco Isovalent is seeking a seasoned Quality Assurance Lead to oversee the development and execution of test plans, ensuring the quality of enterprise releases used by customers.About this roleThe ideal candidate will have a proven track record of giving feedback to engineering teams and increasing product quality. They will be responsible for developing,...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job Title: Local Quality OfficerCSL Behring is seeking a highly skilled Local Quality Officer to join our team. As a key member of our quality assurance team, you will be responsible for maintaining Quality Assurance Systems and ensuring compliance with company standards and regulatory guidelines.Key Responsibilities:Develop and implement quality systems to...