Offre d'emploi : QA Project engineer

Région
Neuville, Philippeville
Publication
mercredi 12 janvier 2022
Date limite
dimanche 31 juillet 2022
Type de contrat
CDI
Temps de travail
Temps plein
Langue(s) souhaitée(s)
Anglais, Français

Based nearby Philippeville, OOC is the  design and development branch of ORA www.oraneptis.com  a world leader in the manufacturing of automated radiosynthesis modules for radiopharmacy and organic chemistry.  ORA, through its brand Neptis®, offers innovative solutions in the radiopharmaceutical field for the production of radiotracers for academic, research and clinical needs worldwide. The company is ISO13485:2016 certified for medical devices.

As part of the development and the spreading of its activities, OOC is actively looking for a dynamic collaborator (f/m):

QA project engineer 

What is your role:

You will work closely with the CTO, R&D PhDs and QA Manager to provide support in terms of front office administrative management. The key tasks involve:

  • Being the R&D and QA partner of our medical device development projects and other upcoming projects in organic chemistry.
  • Collaborating with different stakeholders, both internally in Philippeville, but also with the R&D PhDs team based in Liège and Lyon.
  • Being part of the development process in the documentation support, from early innovation in the URS definition, until the tech transfer according to the standard ISO13485 :2016
  • Ensuring proper QA documentation writing at each development stage
  • Monitoring the administration of subsidy files from sponsors (e.g. walloon region or EU).
  • Following up the worldwide patent files status.
  • Supporting QA Manager in the various QMS projects in order to uphold the highest level of quality expected by our pharma customers.

About your ideal profile:

  •  Engineer, Master degree in life sciences or equivalent by experience in engineering, medical device, pharmaceutical, science or other relevant academic fields.
  • Ability to constructively engage your stakeholders to ensure proper documentation follow up.
  • Previous experience of working in a dynamic and international organisation is an advantage.
  • You have a very good knowledge of written and spoken English and French.
  • You are proactive and you combine autonomy with team spirit.  You demonstrate excellent time management and organizational skills.
  • You have the availability to work under pressure and to manage confidential information with discretion.

We offer:

  • A stimulating, human-sized working environment that is in full development;
  • An open and inclusive culture that focuses on people;
  • A company with a creative entrepreneurial spirit;
  • A permanent contract;
  • A competitive salary commensurate with your qualifications and experience, with fringe benefits.

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