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Quality Assurance Associate



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Introductie

Join the experts in transplant diagnostics! To strengthen our team, we are looking for an accurate and quality-driven Quality Assurance Associate, who can translate R&D into QA principles.

Het bedrijf / The company

GenDx is a global leader in molecular diagnostic laboratory solutions for matching donors and patients and monitoring transplant success. We combine our cutting-edge software and reagents for DNA Sequencing HLA typing and Chimerism monitoring with excellent customer support and education. With a highly educat-ed and motivated team of approximately 85 colleagues, we contribute to the quality of life of transplant patients.

Extra info

With a highly educated and motivated team of approximately 85 colleagues, we contribute to the quality of life of transplant patients.
GenDx is located at Utrecht Science Park, The Netherlands.

De functie / The role

As QA Associate at GenDx, you are responsible for quality activities, related to our reagent and software
products and corresponding processes. As part of the QA team, you are working closely together with both the R&D and Operations team. You ensure that the Quality Management System (QMS) complies with the ISO13485 and IEC 62304 standards. Naturally, you are an enthusiastic and driven person, who communicates clearly and enjoys translating QA principles into solutions. A strong desire to continually improve processes characterizes you.

Responsibilities:

- Performing processes according to required quality system standards.
- Preparing, reviewing and maintaining QA documents.
- Supporting activities such as internal and supplier audits.
- Communicating quality assurance information within GenDx.
- Working according to ISO 13485 and IEC 62304 standards.

Het profiel / Your profile

- At least an Applied Sciences degree in molecular biology.
- Relevant work experience in Life Sciences and/or bioinformatics/software development
- Outstanding in keeping overview with attention to detail.
- Good planner, and a great collaborator.
- Effective in communication, both Dutch and English (oral and written).
- You live in the Utrecht area, or are willing to relocate.

Het aanbod / The offer

Join the experts in transplant diagnostics! Do you want to be part of an innovative company that offers excel-lent working conditions and ample time for personal development? Apply now and maybe you will soon be part of the GenDx team.

Reactie / Reaction

For more information you can contact Erica Kremer PhD, Regulatory Affairs Officer, 030 252 37 99.

Do we match?
Send your CV and motivation to Roelien Brommersma MSc, CHRO, hrm@gendx.com. Please mention 2021_11 and your name in the e-mail subject line.

Tenslotte ..... / Finally ....

Unsolicited third party/agency profiles and resumes will not be considered.


Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.


Gegevens

Werkgever:
GenDx
Vacaturesteller:
H.R. Brommersma
Standplaats:
Utrecht

Geplaatst op FMF: 21 september 2021

Branche: Farma & Biotech, Medical, Healthcare
Functie: QA / regulatory, R&D, QC / Laboratory
Opleidingsniveau: HBO / BSc, WO/academisch / MSc
Werkervaring: 0-2 jaar, 2-5 jaar