Vacatures

QA/RA Junior

The company:

Pronova Laboratories develops and registers medical devices for various ailments that are being sold across the world. Pronova is a  growing organization located in Muiden, just outside Amsterdam.

We are looking for an RA/QA junior to assist in core processes that allow development and production of the highest quality standards. Together with our QA/RA manager you will bring our medical device registrations to the next level. You can directly impact Pronova’s quality goals, inspiring others around you in the process.

Aim of the position:

  • Quality (Assist in) Maintaining and updating Pronova’s quality management system, in compliance with MDD/MDR, ISO 13485:2016 and FDA 21 CFR Part 820.
  • Regulatory (Assist in) Composition and submission of product files to relevant authorities and/or Notified Bodies.

Core tasks and responsibilities:

  • Executing Complaint Handling, Non-Conformity and CAPA procedures;
  • Performing internal and external audits;
  • Continuously improving the Quality Management System;
  • Updating product portfolio in compliance with the Medical Device Regulation;
  • Composition of product files and technical documentation;

Job requirements:

  • BSc/MSc in pharmaceutical sciences, life sciences or equivalent;
  • No more than 2 years experience in a medical device quality/regulatory position;
  • Structured and systematic attitude;
  • Talent for organisation and planning;
  • Excellent verbal and written communication skills in both Dutch and English;

Preferred:

  • Knowledge of ISO 13485:2016, 21 CFR Part 820 and MDD 93/42/EEC;
  • Knowledge of Risk Management (ISO 14971:2012), Clinical Evaluations (MEDDEV 2.7.1 rev 4) and Clinical Investigations (ISO 14155:2011);
  • Knowledge of MDR EU 2017/745 and FDA 510(k) procedures.

Application process

Are you interested and do you fulfil the requirements? Please send your resume and a detailed motivation letter in English to info@pronovalab.com. If eligible, you may expect an invitation for an interview within one month.

Questions about this vacancy?

Please contact Pronova Laboratories at +31 (0) 29 4466611.

© Pronova Laboratories - BTW-nummer NL 80 92 06 353 B02 - KvK-nummer 17126800

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