Project Engineer Medical Devices
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 and Pharmaceutical organization, based in Antwerpen Belgium.
is a large pharmaceutical and medical devices company HQ is in the USA, but the RHQ is based in Belgium.
ROLE DESCRIPTION
De QA Project Engineer is verantwoordelijk voor het opzetten, implementeren en onderhouden van het systeem van Medical Devices, vanuit QA oogpunt. In deze rol heb je frequente contacten buiten de plant, met andere sites / centers en safety.
RESPONSIBILITIES
- Evaluatie en implementatie van wetgeving:
o FDA 21CRF 820
o EU MDD 93/42/EEC
o ISO 13485:2016
- Implementatie Risicomanagement en onderhoud risicodocumenten – ISO 14971
- Digitalisering technical files en onderhoud technical files
- Opbouw systeem design controle/ Design history file
- CE markering nieuwe medical devices
- Uitbouwen systeem Vigilance en Post market surveillance
REQUIREMENTS
- Masteropleiding : ingenieur, farmacie of wetenschappen
- Min. 3 jaar relevante werkervaring
- Ervaring in het opzetten van kwaliteitssytemen
- Ervaring in projectmanagement
- Ervaring met interpreteren van de regelgeving rond Medical Devices
- MS Office toepassingen
- Goede kennis van Nederlands en Engels
- Sterke team player
- Nauwgezet werken
- Klantgerichte ingesteldheid
- Sterke communicatieve en sociale vaardigheden
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.
