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.
- 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.