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Quality Assurance Engineer

Medical
Groningen
English

Description:

We are looking for a Quality Assurance Engineer for a medical devices Centre of Excellence based in Groningen. Are you an experienced QA Engineer with experience in Risk Management looking for a chance to work for a market leader within pharmaceutical and medical devices solution? Do you have experience with validation of processes and products within a regulated environment (GMP, MDD, CFR 820)? Please feel free to let us know by using the apply button below.

Your tasks include:

  • General support in the quality department, including reviewing documentation, providing advice on drafting protocols or procedures on a variety of subjects;
  • Perform and assess statistical analyzes and support in the implementation of statistical process control techniques, sampling schemes and other quality techniques;
  • Assist during external (e.g. DEKRA / FDA) and internal audits;
  • Performing non-conformance / CAPA root cause investigations and defining action plans.

As a Quality Assurance Engineer you are aware of the applicable regulations regarding the development and production of medical devices and you know the internal procedures. You have a pragmatic and critical attitude that ensures that the site is in compliance and delivers products of high quality.

You will join an innovative biotech company with a global presence. You will work in multidisciplinary teams of dedicated and talented individuals with a common goal: to make the world a healthier place!

Requirements:

The Quality Assurance Engineer has the following qualifications and experiences: * Relevant work experience preferably in the pharmaceutical or medical device industry; * A Master's degree (technical, life science or related); * Experience in Risk Management; * Knowledge of validation of products, equipment and processes; * Experience in a regulated environment e.g. in compliance with GMP, MDD or ISO regulations; * Accuracy and focus on quality; * Excellent command of the Dutch and English language.