Do you have experience in medical device industry and would you like to work as a Validation Engineer Medical Devices? Read this vacancy and find out if this function fits you!

Functie

For the Product & Process Development unit, the company is 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).

Functie eisen

  • 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);
  • Experience with GAMP5, ISO-13485, CFR21, MDR would be a pre;
  • Experience in medical device industry would be a pre;
  • Good written and oral English (C1), Dutch is an advantage;
  • Software: Jira, X-Ray, Minitab;
  • Some flexibility in working hours is required;
  • Must be able to work on multiple simultaneous tasks with limited supervision; 
  • Quick learner, motivated self-starter; 
  • Excellent customer service, interpersonal, communication and team collaboration skills; 
  • Able to follow change management for internal guidelines.

Aanbod

This is a responsible job with good employment conditions.

Sollicitatie Procedure

Contactpersoon voor deze functie als Validation Engineer Medical Devices is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: joost@xdes.nl Kenmerk: 10776.

Solliciteer nu
  • Functienaam:
    Validation Engineer Medical Devices
  • Locatie:
    Groningen
  • Branches:
  • Opleidingsniveau:

Solliciteer

Vacature: Validation Engineer Medical Devices

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