Quality Engineer

Vor 7 Tagen

Lausanne, Schweiz Novostia Vollzeit

Novostia is a start-up company developing a unique heart valve prosthesis with the mission to improve the quality of life for patients suffering from heart valve disease, especially children and young patients.

Take up new challenges and join our innovative and dynamic team

Your main role

Reporting to the Quality, Regulatory and Clinical Affairs Manager, your principal duties and responsibilities will be to:

  • Serve as the quality reference for development and implementation of quality documentation related to the design technology and to the manufacturing process (i.e. Specifications, Validation Master Plan, Quality Plan, Process Validation Protocols and Reports).
  • Interface with all partners involved in the development, manufacturing, and quality activities.
  • Manage Process Risk activities at Suppliers (pFMEA).
  • Participate in the development, implementation and validation of methods and procedures for inspecting, testing, and evaluating product quality and performance in collaboration with suppliers.
  • Review and maintain Device History Records.
  • Responsible for product batch release.
  • Lead and coordinate the CAPA and NC workflow, ensuring the timely completion of NC, CAPA and audit actions.
  • Provide Statistical Data /Trends Analysis on CAPAs, NCs and other quality metrics.
  • Support Quality System improvement activities.
  • Support training and alignment for changes related to products, processes and system related issues.
  • Conduct Data driven analysis based on requirements.
  • Support the maintenance of the Quality System according to ISO 13485.
Your profile
  • Min. Master’s degree in Biomedical, Mechanics or Micro-technologies Engineering.
  • Min. 4 years’ experience as a Quality Engineer ideally working with Class III implantable medical devices (Senior welcome).
  • Consistent background and knowledge of the Medical Device Industry standards and Regulations (ISO 13485, ISO 14971, MDR 2017/745).
  • Strong knowledge of statistical analysis.
  • Analytical Problem-solving skills.
  • Rigor, attention to details, dedication, self-driven, and sense of responsibility.
  • Ability and willingness to work in a start-up environment.
  • Work independently with established timelines.
  • French or English mother tongue, other language level C1+ (German an advantage).
Additional information
  • Starting date: To be discussed
  • Activity rate: 80-100%
  • Applicant must hold a valid Work Permit in Switzerland.
  • Recruitment agencies: please abstain.

If you are highly motivated by this position and believe you meet at least 80% of the qualifications, please tell us how you envision your career in the next 5 years and how you could contribute to the success of Novostia in the current phase and for the next 3 years.
Your primary contact for this position is: p.boissier@novostia.com

#J-18808-Ljbffr

  • Quality Assurance Engineer

    vor 3 Wochen

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    {"title": "Quality Assurance Engineer", "content": "Job SummaryCAPGEMINI ENGINEERING is seeking a Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will be responsible for collaborating with cross-functional teams to address quality issues and implement corrective actions.Key ResponsibilitiesDevelop and maintain quality...

  • Quality Engineer

    Vor 5 Tagen

    Lausanne, Schweiz The Biopôle Vollzeit

    Responsibilities:Serve as the quality reference for development and implementation of quality documentation related to the design technology and to the manufacturing process (i.e. Specifications, Validation Master Plan, Quality Plan, Process Validation Protocols and Reports).Interface with all partners involved in the development, manufacturing, and quality...

  • Quality Assurance Engineer

    vor 3 Wochen

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    Job Description:As a Quality Assurance Engineer at Capgemini Engineering, you will play a crucial role in ensuring the quality of our products and services. Your primary responsibility will be to collaborate with cross-functional teams to identify and address quality issues, and implement corrective actions to prevent their recurrence.Key...

  • Quality Assurance Engineer

    vor 3 Wochen

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    Job Description:We are seeking a highly skilled Quality Assurance Engineer to join our team at Capgemini Engineering.Key Responsibilities:Collaborate with cross-functional teams to identify and address quality issues, implementing corrective actions to ensure product excellence.Develop and maintain quality control and assurance documentation, procedures, and...

  • Quality Assurance Specialist

    vor 3 Wochen

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    Join Our Team as a QA/QC EngineerAt Capgemini Engineering, we're committed to excellence, innovation, and teamwork. We're looking for a skilled QA/QC Engineer to join our dynamic team in Switzerland.About the RoleWe're seeking a detail-oriented and analytical individual to collaborate with our cross-functional teams to ensure the highest quality standards....

  • Quality Engineer

    Vor 7 Tagen

    Lausanne, Schweiz ALTOGEN AG Vollzeit

    ALTOGEN is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise, and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...

  • Quality Assurance Specialist

    Vor 4 Tagen

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    At Capgemini Engineering, we are committed to excellence and innovation. We are seeking a highly skilled QA/QC Engineer to join our team in Switzerland.The ideal candidate will have a strong background in quality control or assurance methodologies and tools, as well as excellent problem-solving and analytical skills.Key responsibilities will include...

  • Quality Assurance Specialist

    Vor 5 Tagen

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    Join Capgemini Engineering as a QA/QC Engineer and be part of our team that values excellence, diligence, responsibility, dynamism, and innovation.We are looking for a skilled QA/QC Engineer to collaborate with our cross-functional teams to address quality issues and implement corrective actions.Key Responsibilities:Develop and maintain quality control or...

  • Quality Assurance Specialist

    vor 4 Wochen

    Lausanne, Waadt, Schweiz Limula Vollzeit

    Join Limula's Team as a Quality EngineerLimula SA is a Life Science Tools company based in Switzerland, dedicated to making highly personalized cell therapies accessible to patients worldwide. Our mission is to provide innovative manufacturing solutions that enable the production of 'living treatments' at scale, while maintaining the highest quality...

  • Quality Assurance Intern

    vor 5 Monaten

    Lausanne, Schweiz ONWARD Medical Vollzeit

    At ONWARD we're looking for a Quality Assurance Intern to join our team. Full-time - Lausanne **About the job**: Reporting to the Senior Quality Assurance department, you will be under the supervision of the Quality Assurance & EHS manager. Your main role will be to support the deployment of the Quality Management System, and in particular the update to...

  • Quality Validation Engineer

    vor 2 Wochen

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    Job DescriptionAs a Quality Validation Engineer at Capgemini Engineering, you will play a crucial role in ensuring the compliance of our processes, instruments, and facilities with regulatory standards. Your expertise will be instrumental in developing and executing validation protocols, commissioning and qualifying utilities and equipment, and contributing...

  • Quality Assurance Specialist

    vor 1 Woche

    Lausanne, Waadt, Schweiz AXEPTA SA Vollzeit

    Job Title: QA Supplier EngineerWe are seeking a highly skilled QA Supplier Engineer to join our team at AXEPTA SA. As a key member of our global team, you will be responsible for the management of all suppliers at our pharmaceutical manufacturing site in the canton of Vaud.Key Responsibilities:Coordinate daily quality assurance activities related to supplier...

  • Quality Assurance Specialist

    vor 1 Monat

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    {"h1": "Join Our Team as a QA/QC Engineer at Capgemini Engineering Switzerland", "p": "At Capgemini Engineering Switzerland, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace and invite you to be part of our success story, where we provide training, tools, and foundations for your professional and personal...

  • Quality Assurance Specialist

    vor 1 Monat

    Lausanne, Waadt, Schweiz Capgemini Vollzeit

    About UsAt Capgemini Engineering Switzerland, we value excellence, innovation, and teamwork. We offer a dynamic work environment and opportunities for growth and development. We are seeking a skilled QA/QC Engineer to join our team.Job ResponsibilitiesWe are looking for a detail-oriented and analytical individual to collaborate with cross-functional teams to...

  • Quality Validation Engineer

    vor 3 Wochen

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    CQV Engineer Job DescriptionAt Capgemini Engineering, we are committed to excellence, diligence, and innovation. We offer a dynamic and inclusive work environment where you can grow professionally and personally.We are seeking a highly skilled CQV Engineer to join our team.Key Responsibilities:Develop and execute validation protocols to ensure compliance...

  • Quality Assurance Specialist

    vor 1 Woche

    Lausanne, Waadt, Schweiz Axepta SA Vollzeit

    Job DescriptionWe are seeking a highly skilled Quality Assurance Supplier Engineer to join our team at Axepta SA. As a key member of our global team, you will be responsible for the management of all suppliers at our pharmaceutical manufacturing site in the canton of Vaud.Key Responsibilities:Coordinate daily quality assurance activities related to supplier...

  • Process Engineer

    vor 3 Wochen

    Lausanne, Waadt, Schweiz isover Vollzeit

    Join Our Team as a Process EngineerWe are seeking a highly skilled Process Engineer to join our team at CRIR, a leading company in the field of insulation materials. As a Process Engineer, you will play a key role in the development and industrialization of new technologies, ensuring the quality and efficiency of our processes.Main ResponsibilitiesConduct...

  • Quality Validation Engineer

    vor 3 Wochen

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    Job DescriptionCAPGEMINI ENGINEERING is seeking a skilled CQV Engineer to join our team.Key Responsibilities:Develop and execute validation protocols to ensure compliance with regulatory standards.Commission and qualify utilities, equipment, and cleaning processes.Contribute to documentation of CQV activities.Collaborate with cross-functional teams to...

  • Process Engineer for Industrialization

    Vor 7 Tagen

    Lausanne, Waadt, Schweiz isover Vollzeit

    Join Our Team as a Process EngineerWe are seeking a highly skilled Process Engineer to join our team at the CRIR Center in France. As a Process Engineer, you will play a key role in the development and industrialization of new technologies, working closely with our R&D teams and production site in Lucens, Switzerland.Main ResponsibilitiesParticipate in the...

  • Electronics Design Engineer

    Vor 4 Tagen

    Lausanne, Waadt, Schweiz CAPGEMINI ENGINEERING Vollzeit

    Electronics Design EngineerWe are seeking an Electronics Design Engineer to join our team at Capgemini Engineering. As an Electronics Design Engineer, you will be responsible for designing, testing, and optimizing electronic boards in collaboration with your project team.Key Responsibilities:Design and develop electronic boards, including circuit design,...