Offre d'emploi : QA Project engineer

Based nearby Namur, OOC (branch of ORA) is a world leader in the design, development and manufacturing of automated radiosynthesis modules for radiopharmacy and organic chemistry.  ORA 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 :

  • You will be a Quality Assurance Project Engineer, being the R&D and  QA partner of our medical device device development projects and other upcoming projects in organic chemistry as well.
  • Collaborate with different stakeholders both internally in Philippeville, but also with the R&D PhDs team based in Liège and Lyon.
  • Be a 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
  • Ensure writing proper QA documentation for the development stages
  • Follow the administrative evolvement of budget and subsidy files from RW or EU.
  • Follow the patent files status accross worldwide.
  • Support 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’s degree or equivalent by experience in engineering, medical device,pharmaceutical, science (e.g. m), or other relevant academic fields.
  • Min 5 years of experience within project and QA support in medical devices, chemical or pharma companies.
  • 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 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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