Quality Validation Engineer - Utrecht

Vacancy information

Publication date:May 12 2020
Employment type:Permanent
Sector:Medical Devices
Function Group:Quality/RA

Function Group: Quality/RA / Validation Engineer

Organization

For a rapidly growing medical devices scale-up, we are looking for a Quality Validation Engineer. The organisation develops and produces innovative and life changing electronic medical devices with the goal to give people more time to enjoy life. This organisation is one that people can rely on.

Currently, the organisation experiences tremendous growth, and is expected to become a global leader in the near future. At the moment, about 100 employees work at the organisation which are talented and ambitious professionals who believe in a work hard/play hard approach.

You will be part of the quality department which now consists of 15 employees, and will be reporting directly to the manager Quality Control.

Function

As a Quality Validation Engineer, you are a linking pin in the organisation. You will work with a small team in a highly regulated manufacturing environment and ensure quality, safety and effectiveness.

Key words related to the responsibilities: Calibration; Qualification; Validation; IQ, OQ, PQ

Additionally, your tasks will relate to:

  • Develop quality function within validation processes
  • Drafting validation requirement
  • Plan and monitor design validation testing
  • Validation/testing monitoring and approval
  • Give support to the QA department by training and coaching junior QA engineers

Requirements

A large dose of proactivity is asked for this role. Next to that:

  • Bachelor in quality/biomedical/mechanical field
  • At least three years experience in a similar role at medical devices companies with manufacturing or production environments
  • Knowledge of ISO 13485 and 21 CFR 820
  • European work permit
  • Fluency in English
  • Strong communicator towards all levels of the organisation

Offer

Besides working for a rapidly growing organisation, the company offers you:

  • Expected monthly salary range of €3,000 to €4,500 depending on your experience and expertise
  • 25 holidays and up to 13 ADV (time for time) days per year
  • Defined benefit pension scheme and disability insurance
  • 40 hours per week to be worked anytime between 07:00 to 19:00
  • Assistance for relocation and 30% ruling
  • Team lunches and events outside of working hours
  • Great and relaxing atmosphere in the office
  • Informal dress code

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Saskia Cepella
Consultant Quality & Clinical | Medical Devices

+31(0)6-13143973
+31(0)23-7548660
s.cepella@qtcrecruitment.com

Apply

Contact

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