Publication date:30 juin 2022
Place of work:Route de la Corniche 4, 1066 Epalinges
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 improvements activities (optional).
- Min. Bachelor’s degree in engineering (biomedical, mechanics, micro-technologies).
- Min. 2 years’ experience as an Quality Engineer ideally working with Class III implantable medical devices– Senior 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.
- Good communication skills in English and French (German is a plus).
- Starting date: September 1st or 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
Apply: Write an email
No recruitment agencies please