Quality Engineer

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, dynamic, and passionate team!

Your main role

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

  • Support the development and implementation of quality and regulatory documentation related to the technology and to the manufacturing process (Validation Master Plan, Quality Plan).
  • Interface with all partners involved in the development, manufacturing, quality, and regulatory activities.
  • Manage Process Risk activities at Suppliers (pFMEA).
  • Support Design Risk Management Activities (dFMEA per ISO 14971), including Human Factors assessment (optional).
  • Develop and implement methods and procedures for inspecting, testing, and evaluating the performance of product together with suppliers.
  • Lead Suppliers management (qualification, evaluation, audits...).
  • Establish and maintain product traceability.
  • Develop, lead and coordinate CAPA and Non-Conformities action plan.
  • Provide statistical data/trends analysis on CAPA, Non-Conformities and other quality metrics.
  • Support quality system improvement activities (optional).

Your profile

  • Min. Bachelor’s degree in engineering (biomedical, mechanics, micro-technologies)
  • Min. 2 years’ experience as a Quality Engineer, ideally working with Class III implantable medical devices. Seniors and women are welcome
  • Consistent background and knowledge of the medical device industry regulations.
  • Rigor, attention to details, dedication, self-driven, and sense of responsibility
  • Ability and willingness to work in start-up environment
  • Excellent communication skills in English and French (German is a plus).

Additional information

  • Starting date: To be discussed
  • Localisation: Lausanne
  • Activity rate: 100 % or to be discussed
  • Applicant must be holder of / or eligible for a valid work permit in Switzerland

Send your motivation pitch and your CV directly to the following email address > p.boissier [at] novostia.com