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QA Project engineer

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.

QA Project engineer

Optimized radiochemical applications, Walloon Region
Contract type: 
Permanent, Internship
Categories: 
Project Engineer, Quality Assurance Engineer
Degree level: 
Master