Responsibilities:
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).
Participate in the development, implementation and validation of methods and procedures for inspecting, testing, and evaluating product quality and performance in collaboration with suppliers.
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.
Activity rate: 80-100%.
Applicant must hold a valid Work Permit in Switzerland.
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