Offre d'emploi : 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.