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Quality Engineer R&D

Biocartis

Mechelen, Belgium

Experience Required

  • Preferably>2 years of experience in healthcare industry, preferably in QA;
  • Preferably experience in the medical devices and/or in the IVD industry Knowledge on ISO 13485, 21 CFR part 820 and ISO14971, ISO62366 as well as knowledge on technical standards, e.g. ISO62304 and GAMP;
  • Ability to effectively interact with the project leader and the technical assay development lead when representing the Quality domain.

Education

  • Academic level in Molecular Biology, engineering, chemistry, pharmacy or equivalent.

Purpose of the position:

  • The Quality engineer R&D is responsible to support assay development projects from the quality perspective and is a member of the Menu Development Sphere.

Tasks/outcome domains

  • To support assay development project teams, both internally and with external development partners;
  • To provide input from a quality and compliance perspective;
  • To support the creation of qualification and validation documents in relation with assay projects;
  • To review project documentation, mainly DHF;
  • To own the risk management process within the assay project;
  • To ensure assay-dependent issues, deviations and design changes are adequately investigated and documented;
  • To establish and maintain an adequate quality mindset in the assay projects;
  • To provide generic QA support to Menu Development;
  • Contribute to equipment, method and supplier qualifications;
  • Contribute to continuous process improvements and to support the SOP creation or updates;
  • Contribute to event and change management related to menu Development: ensuring that assay-independent issues, deviations and changes are adequately assessed, investigated and documented;
  • To participate in company-wide QA support such as performing internal audits.

Profile and Competencies

  • Academic level in Molecular Biology, engineering, chemistry, pharmacy or equivalent;
  • Preferably>2 years of experience in healthcare industry, preferably in QA;
  • Preferably experience in the medical devices and/or in the IVD industry;
  • Knowledge on ISO 13485, 21 CFR part 820 and ISO14971, ISO62366 as well as knowledge on technical standards, e.g. ISO62304 and GAMP;
  • Ability to effectively interact with the project leader and the technical assay development lead when representing the Quality domain;
  • Advanced knowledge, orally and in writing of Dutch and English;
  • Highly accurate;
  • Achievement and customer service oriented mindset;
  • Able to work autonomously;
  • Conceptual thinking;
  • Good decision-making skills;
  • Hands on mentality;
  • Team player who likes to develop others.

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