Quality Assurance Engineer

Baan gegevens

  • Bedrijf: Independent Recruiters
  • Plaats: Groningen
  • Plaatsingsdatum: 20-01-2019
  • Werkniveau: Universitair
  • Werkervaring: 3 - 5 jaar ervaring
  • Dienstverband: Vast contract


Algemene omschrijving

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)? Then this might be your new professional challenge. Please feel free to let us know by using the apply button below.

Quality Assurance Engineer will join the QA team within the Center of Excellence in Groningen. The specialisation of the Center of Excellence is development and manufacturing of innovative solutions for the surgical ophthalmic market, mainly intraocular lenses (IOLs).

In this role you contribute directly to product and process development projects. You can think of projects to develop a new Intraocular Lens, or to further develop technology to produce the lenses. Within development projects you are the owner of risk management and you set up risk management documentation (FMEA) with a multidisciplinary team. You ensure that the change control procedures are correctly applied and you review project documentation. Preferably you have knowledge of process and product validation.

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.

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.

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!

Gestelde eisen

Master's degree, Few years of experience in a similar role, Risk Management.

Uren

32-40 hours

Informatie over Independent Recruiters

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)? Then this might be your new professional challenge. Please feel free to let us know by using the apply button below.

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  • Quality Assurance Engineer

    Toegevoegd op 11-02-2019 door Independent Recruiters

    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...

    Independent Recruiters

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