QA Engineer R&D Platform

21/04/20

Location

Generaal de Wittelaan 11B Mechelen Belgium

Function type

Quality

Vacancy

About Biocartis

Biocartis is an innovative molecular diagnostics company committed to revolutionize molecular testing with its unique proprietary IdyllaTM platform. We provide next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and the healthcare industry, with a focus on oncology.
Biocartis’ proprietary molecular diagnostics (MDx) IdyllaTM platform is a fully automated sample-to-result, real-time PCR system that offers accurate, highly reliable molecular information from virtually any biological sample, in virtually any setting, allowing fast and effective treatment selection and treatment progress monitoring.
Biocartis employs over 450 people and is headquartered in Mechelen, Belgium.

QA Engineer R&D Platform

The QA engineer R&D platform supports the platform/product engineering teams during Idylla platform development and life cycle management activities from the Quality perspective.

 Accountabilities

The QA engineer R&D Platform is responsible:

  • To provide input from a quality and compliance perspective to the platform/product engineering teams;

  • To support the maintenance of the platform Design History File and to review them for adherence to relevant QMS processes;

  • To support the interface between Platform and test applications from a Quality perspective;

  • To follow-up Quality events (deviations, design changes) related to the Idylla platform, more specifically to support to event owners and/or stakeholders with regard to investigation, root cause analysis and definition/implementation of action plans related to software products; to verify on completeness of the investigation and to motivate impact assessments and disposition decision, if applicable;

  • Contribute to equipment, method and supplier qualifications;

  • Contribute to continuous process improvements and to support the SOP creation or updates related to software life cycle management;

  • To own the Platform risk management file;

  • To participate in internal and external 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;

  • Fundamental understanding on the Idylla platform and software architecture including the interface with test applications, as well as the applicable configuration management processes;

  • Expert in risk management;

  • Theoretical knowledge on design control, method validation, equipment/tool qualification, statistical techniques;

  • Skilled in event management;

  • Ability to effectively interact with the project leader and the technical assay development lead when representing the Quality domain;

  • Skills: Highly accurate, Conceptual thinking, Hands on, Developing others, Teamplayer;

  • 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.

Interested? Please apply via HR@biocartis.com

Job application