Technical Documentation
Location: NetherlandsSIRE 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 Zuid-Holland Netherlands.
Medical Devcies manufacturer
ROLE DESCRIPTION
Provide technical documentation and help with internal audits
RESPONSIBILITIES
• Design solutions
• CRD
• DHIF
• Technical datasheet
• FMEA
• RM plan
• RM report
• ISI
• Design Description
• Specification
• Packaging description
• Manufacturing flowchart
• General product description
• Comparison with existing approved devices / SE discussion
• Marketing material (overview/reference)
• Verification Protocol and report
• Clinical evaluation protocol and report
• Validation Protocol and report
• EtO residue protocol and report
• LAL testing protocol and report
• Biocomp protocol and report
• Adoption validated sterilization process
• Adoption shelf life
• Adoption packaging integrity
• Usability / human factors report
• Essential requirements list
• Summary of technical file
• Conformity report (TRF)
• Overview of reports
• Overview of specifications
• Update HIS
• Upload documents in MM
REQUIREMENTS
- Know some of above points
- Good English
- available immediately
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.