Director of Quality Assurance

vor 2 Monaten


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, 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, 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, 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 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, Schweiz Johnson & Johnson Vollzeit

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the...


  • Bern, Schweiz BMK Recruitment Vollzeit

    We are currently looking on behalf of one of our clients based near Bern for a Quality Assurance Manager. This is a permanent role. Aufgaben - manage tests on products at different stages of production to ensure the quality level - define the measurement procedures - be the central point of contact for product test-related matters - be the central point of...


  • Bern, Schweiz Consultys Vollzeit

    Due to the substantial increase in our business, we are currently looking for a Quality Assurance Specialist, to join our team of consultants.Supports creation and implementation of the aseptic operator training program for the siteCreation and update of procedures and risk assessmentsEnsures adherence to global procedures and standardsCreation of SOPs in...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job OverviewWe are seeking a senior quality management professional to lead our pharmaceutical operations in Bern, Switzerland. As Senior Director, Quality Management, you will be responsible for ensuring the highest quality standards in our plasma fractionation and finished dosage form manufacturing site.Key ResponsibilitiesDevelop and implement quality...


  • Muri b. Bern, Bern, Schweiz Autodesk Vollzeit

    Quality Assurance and Support SpecialistWe are seeking an experienced Quality Assurance and Support Specialist to join our team at Autodesk. As a key member of our Customer Support Team, you will play a critical role in ensuring the highest level of quality in our products and services.ResponsibilitiesQuality Assurance: Identify and deliver trend analysis...


  • Bern, Schweiz Consultys Vollzeit

    MissionsDue to the substantial increase in our business, we are currently looking for a Quality Assurance Specialist to join our team of consultants.Supports creation and implementation of the aseptic operator training program for the site.Creation and update of procedures and risk assessments.Ensures adherence to global procedures and standards.Creation of...

  • Quality Assurance Tester

    vor 5 Monaten


    Bern, Schweiz Oliver James Associates Vollzeit

    Quality Assurance Tester Bern Hybrid We've partnered with one of the leading health techs whose mission is to shape the future of healthcare technology. They are seeking individuals who are passionate about innovation and eager to contribute to the ongoing development of the hospital information system. They are dedicated to revolutionizing healthcare...


  • Bern, Bern, Schweiz CSL Behring AG Vollzeit

    We are seeking an experienced Quality Assurance Manager to join our team at CSL Behring AG. This role will partner closely with Global Quality Systems and other Quality functions to continuously improve and standardize quality processes and standards across the network.About this RoleThis is a full-time opportunity where you will be responsible for leading...


  • Bern, Bern, Schweiz Atanis Biotech AG Vollzeit

    At Atanis Biotech AG, we strive to make allergy diagnosis simple and safe for both patients and physicians.Using cutting-edge technology, we have established a method to mimic allergic reactions in a test tube, keeping potentially harmful allergens away from the patient during diagnosis. All we require for the diagnostic work up is a small sample of blood.To...


  • Bern, Bern, Schweiz Randstad - Medium prio Vollzeit

    Job OverviewWe are seeking a skilled Quality Assurance Specialist to join our team in Bern, Switzerland. As a key member of our Quality department, you will be responsible for ensuring the GMP-compliant production of active ingredients and drugs for clinical trials and market launch.Main Responsibilities:Develop and implement training programs for personnel...


  • Bern, Schweiz Johnson & Johnson Vollzeit

    The Quality Excellence Director QA/QS, Advanced Therapies Platform, is responsible for delivering the Quality Assurance (QA) and Quality Systems (QS) platform strategy. This role will develop, execute, and monitor Advanced Therapies Quality (ATQ) projects, budget and strategies, and establish robust business and quality processes and systems to monitor...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job OverviewWe are seeking a Senior Quality Assurance Manager to oversee the quality of our Contract Manufacturing Organizations (CMOs). As part of our global team, you will be responsible for managing and supporting production efforts at our CMO partners.


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    Job DescriptionCandidates with a background in quality management are sought after to lead the Site Quality function at CSL Behring AG in Bern, Switzerland. This is an opportunity for individuals with experience working with GMPs across the pharmaceutical industry.We are seeking someone who can thrive in a fast-paced environment and collaborate with local...


  • Bern, Bern, Schweiz CSL Behring AG Vollzeit

    Job OverviewCareer Opportunity at CSL Behring AG: Quality Assurance Manager - Pharmaceutical ManufacturingResponsibilities and TasksAct as site Bern agent of the Globally Owned Processes Quality Management System.Exercise site Bern ownership, focusing on the Deviation Management System.Trend quality in areas of responsibility.Support quality-related projects...


  • Bern, Bern, Schweiz CSL Behring AG Vollzeit

    **Quality Assurance and Compliance Expert Wanted**We are seeking a highly skilled Scientific Expert for Quality Assurance and Compliance to join our team at CSL Behring AG.As a Senior Scientific Expert, you will be responsible for providing Quality Assurance oversight and facilitating quality decisions jointly with stakeholders in the areas of maintenance,...


  • Bern, Bern, Schweiz Gi Group SA Vollzeit

    About the Role:We are looking for a skilled Software Quality Assurance Engineer to join our team at Gi Group SA. As an Agile Software Tester, you will be responsible for ensuring the highest quality of our software products.Responsibilities:Develop innovative customer solutions for an exceptional user experienceCreate test cases and execute manual and...