Description:
Validation Engineer Medical Devices
For the Product & Process Development unit within the Surgical Vision in Groningen, we are looking for a validation engineer for various (CSV, Computer System Validation) projects. Term 12 months with the possibility of extension.
Tasks:
- Drafting and performing validations (in collaboration with Subject Matter Expert (SME)):
- Drawing up requirement specifications and/or user stories
- Creating and executing test protocols
- Written report of protocol execution
- Where applicable, electronic reporting of protocol export
- Handling deviations and/or defects and communication with Validation Review Board (VRB)
Profile:
- Required
- Experience with GMP (preferably GAMP5), validating (automated) (measurement) equipment and the implementation and documentation thereof
- Experience with CSV, process and equipment validation
- Contractor will be supervised and supported by the relevant SMEs, but will have to be able to work independently as much as possible as soon as possible
- Follow and keep up to date the required training courses in a timely manner. The contractor is assigned an extensive curriculum in the LMS (Learning Management System)
- Affinity with quality environments (QA)
- Desired/Pre
- Experience with GAMP5, ISO-13485, CFR21, MDR
- Experience in medical device industry
- Languages: good written and oral English (C1), Dutch is an advantage
- Software: Jira, X-Ray, Minitab
Location: Groningen
Start Date: ASAP
If you are interested in the above description, apply with your CV
For more information, please contact Ernest Banor on +31 (0)20 20 44 502 or at e.banor@panda-int.com