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!
The companyOur client is a professional Medical Devices organization, based in Antwerpen Belgium. Company in IVD, Medical Devices.
Role description- The RA/QA Project Manager will be responsible for managing QMS harmonization and product conformity findings work.
- The RA/QA Engineer is also responsible for identifying, evaluating, and ensuring meaningful compliance with all applicable laws, regulations, and standards
- Lead a cross functional team consisting of QA and RA team members between two organizations and manage QMS procedures and Tools harmonization tasks.
- Lead multiple cross functional team consisting of Marketing, R&D, Manufacturing, QA, RA etc. to address audit findings
- Assist in writing quality and regulatory documents like validation plan, protocols, and reports.
- Ensure Product Labeling, SDS, CofA complies to regulations, standards and company procedures.
- Collect, compile and manage all the QMS Supplier QA Agreements and ensure they are up-to-date and current.
- Assist in QMS ISO 13485 Certificate transfer to new notified body
- Report and escalate issues to management as needed. Successfully manage the relationship with all stakeholders. Create and maintain comprehensive project documentation.
- Provide weekly report on status of all the QMS and product conformity finding work activities.
- Ensure all the projects are delivered on time and within scope
Requirements- Bachelors or Master’s degree in Biological Sciences or equivalent
- 4-5 years of quality work experience
- Working knowledge of Genomics, biological reagent, instruments, software and assay work flow
- Good knowledge of ISO 13485, EU IVDD and FDA QSR quality management system requirements and IVD products.
- Up to 10% travel may be required for meetings and training.