SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Medical Devices organization, based in Genf Switzerland.
They produce electrical medical devices, IEC 60601, ISO 13485 certified
We are looking for a Quality Engineer with expertise in the field of quality assurance in Class II IEC 60601 compliant devices. Your role is to contribute to the development and maintenance of Medical Devices, in order to assure that the development process and product design meet regulatory and customer (quality) requirements and results in products that are safe and effective for their intended use.
Please note: This is a TEMP role for 9 months.
- As a member of multidisciplinary R&D project teams, assure that products and manufacturing processes are developed in accordance to the requirements of the QMS.
- Advise management about development milestone passing, release of products for formal verification and validation, release of products for clinical tests and release of final product and manufacturing process design for commercial delivery.
- Support the project leaders and project team members in applying design control rules and QMS processes and procedures.
- Organize and facilitate Product Risk Management based on ISO-14971.
- Establish the Product Quality Plan, contribute to its execution and report the status at milestones and product release moments.
- Participate in the development problem handling and change control to assure that problems and design changes are adequately analyzed, solved, verified, released and documented.
- 2-5 years working experience in the medical devices industry
- Previous Quality Assurance or Regulatory Affairs experience
- Fluency in French and English
- Knowledge of IEC 60601 a huge plus