von: Novostia | localité: EpalingesN: Novostia
Novostia is a clinical stage company founded in April 2017 that is developing a breakthrough heart valve prosthesis offering superior benefits and better quality of life to people suffering from heart valve disease.
Responsibilities and Duties
Reporting to the Quality, Regulatory and Clinical Affairs Manager, your principal duties and responsibilities will be to:
- Support/lead the development and implementation of quality documentation related to the technology and to the manufacturing process (i.e. Specifications, Validation Master Plan, Quality Plan, Validation Report).
- Interface with all partners involved in the development, manufacturing, and quality activities.
- Manage Process Risk activities at Suppliers (pFMEA).
- Support Design Risk Management Activities (dFMEA per ISO 14971), including Human Factors assessment (optional).
- Develop, implement and validate methods and procedures for inspecting, testing, and evaluating the quality and performance of product together with suppliers.
- Lead Suppliers Management (qualification, evaluation, audits…).
- Review and maintain Device History Records.
- Develop, lead and coordinate CAPA and Non-Conformities process.
- Provide Statistical Data /Trends Analysis on CAPA, Non-Conformities and other quality metrics.
- Support Quality System improvements activities.
The expected 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.
- Willingness to take on responsibility, possible career development in the short-to-medium term.
- Rigor, attention to details, dedication, self-driven, and sense of responsibility.
- Ability and willingness to work in start-up environment.
- French or English mother tongue, other language level C1 (German an advantage).
- Starting date: To be discussed.
- Location: Lausanne
- Activity rate: 80-100 %
- Applicant must holder 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 5 coming 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:firstname.lastname@example.org