Project Engineer Devices (Product Support)
Skilyrði:QA/Test
For a pharmaceutical company in Antwerp we are looking for a Project Engineer Devices to participate in a multidisciplinary team to ensure the completion of a transfer.
Within the international Co-development (R&D + production) team the Project Engineer is responsible for
- Device verification and validation support activities
- Defining control strategy; incoming inspection, in process and release testing
- Development of lab methods (including determination of equipment)
- Defining technical specifications
- Application of risk assessment techniques (FMEA is only an example of a tool for risk assessment)
- Use of trouble shooting techniques (DMAIC, six sigma tools, green belt certification,…)
- Technical writing: protocols, reports, SOPs
- Day to day communication with team members as well as production, lab, QA, Procurement, Suppliers
- Industrial engineer, civil engineer, bio-engineer
- At least 3 years of relevant experience in projects in the pharmaceutical, chemical or other industry.
- Experience with product design and assembly of components is an asset as well as knowledge of medical devices, product testing/qualification, designing technical specifications, injection moulding.
- Dynamic and assertive; mature person who can quickly become an appreciated team member
- Respect for agreed timing and decisions
- In favour of a pragmatic approach, hands-on
- Good communicator, human interactor skills
- Good analytical skills – positive attitude to deal with problems