QA Engineer R&D

☞ Biocartis

View: 175

Update day: 26-11-2025

Location: Mechelen Antwerp

Category: High Technology Design - Web Quality Assurance / Quality Control

Industry: Medical Equipment Biotechnology Research

Position: Mid-Senior level

Job type: Full-time

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Job content

The Quality engineer R&D is responsible to support assay development projects from the quality perspective.

Accountabilities

To support assay development project teams, both internally and 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 requirements

  • 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
  • Skills: Highly accurate, Achievement Orientation, Customer Service orientation, Conceptual thinking, Decision-making, Hands on, Developing others, Team Player;
  • Languages: advanced knowledge, orally and in writing of Dutch and English;
  • PC skills:
  • MS Office;
  • Electronic Document Management System (MasterControl);
  • Quality Event Monitoring System (MasterControl).

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.

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Deadline: 10-01-2026

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