Software Quality Engineer

Noord Brabant - Nederland - Life Sciences & Health Care - Medische apparatuur - Wetgeving - WO Bachelor

Can you be independent and take a pro-active, constructive and immediate approach to ensure compliance with quality systems and regulations?
In this role, you will be part of the Quality & Regulatory team working on a project with focus on validation activities to improve critical processes and tools incorporating initiatives and changes for meeting regulation requirements and improving compliance.

Vragen? Neem contact op

Valerija Usova, Consultant

Solliciteer

Over deze functie

As a software quality engineer you are responsible for end to end approach for defining the scope of the work needed, alignment with global teams working on the same project in different areas of business. In this function you will ensure plans are realized, drive and implement defined actions timely in an effective manner, as well as review and approval of validation deliverables, including but not limited to tool classification / risk analysis, validation plan, user requirements specification, test protocols and reports, etc. You will be performing testing of software tools and applications for local implementation. You will also coordinate with E2E validation team and local QMS stakeholders and approvers and report on status to Q&R, the business and project management. In this role you will ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process in compliance with QMS, prior to issuance.

Over jou

  • A Masters or Bachelor degree in Engineering
  • 3-5 years of experience with computer system validation
  • Good understanding of change management theory, techniques and how to implement them into a project
  • Understands how to address different types of resistance to change
  • Knowledgeable of 21CFR part 820 /11, IEC62304, ISO13485, ISO14971, EU MDR, V-model methodology and guidance documents: GPSV / AAMI TIR36
  • Able to coordinate between different functions and ensure integrated plan will be executed
  • Fluent in English language
  • Can operate both on strategical as tactical level w.r.t. project approach, priorities, risk management etc.

Wat wij bieden

Brunel supports your international career: since you are living in another country and probably don’t immediately know how to find your way in the Netherlands, Brunel can help you with this. As an international company, we know better than anyone what it is like to move to a foreign country for work. This is why we can arrange the most important things - including those that don’t involve your job - for you and your family so that you can fully focus on your career in the Netherlands. We will support you by housing, administrative matters and health insurance, but also we support by education and other facilities to make the international career as pleasant as possible.

Over ons

Brunel is an international organization which can offer work on exciting and challenging projects in collaboration with our partners within various industries. These sectors offer opportunities to participate on the development of new technologies amongst world class organizations. Our industrial partners seek the best professionals who possess the ambition and enthusiasm to excel.

Since its establishment in 1975 Brunel developed itself in an international organization with over 10.000 employees. Brunel Engineering is specialized in secondment of technical specialists in all technical fields. The sectors in which Brunel Engineering is active are High-tech, Production, Construction, Infrastructure and Industry. Brunel is also dedicated to the personal development of its employees and supplies them with an extensive training program.

Samenvatting

  • Vacature nummer: PUB183770
  • Standplaats: Noord Brabant
  • Markt: Life Sciences & Health Care
  • Uren per week: 40
  • Branche: Medische apparatuur
  • Opleidingsniveau: WO Bachelor
  • Expertisegebied: Wetgeving
  • Sluitingsdatum: donderdag 13 december 2018
Solliciteer

Vragen? Neem contact op

VU

Valerija Usova

Consultant Brunel Netherlands Eindhoven

+31 40 257 8088

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