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23.08
2024
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 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).
- Support Design Risk Management Activities (dFMEA per ISO 14971), including Human Factors assessment (optional).
- Participate in the development, implementation and validation of methods and procedures for inspecting, testing, and evaluating product quality and performance in collaboration with suppliers.
- Lead Suppliers Management (qualification, evaluation, audits...).
- 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
- 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:
p.boissier@novostia.com
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