QA RA Consultant
Location: BelgiumSIRE 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 COMPANY
Our 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
RESPONSIBILITIES
See above.
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.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.
