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
- 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: