For our Swiss customer located in Basel we are currently looking for (m/f) a Medical Device Senior Technical Expert
• Type of placement: 5 months, external contract with possible long term extension
• Company: major Pharma company in Basel area
The successful candidate for this position will support change control activities within the development and life cycle management of parenteral delivery systems, e.g. drug/device combination products and medical devices.
An ideal candidate would have a relevant degree in engineering and at least 5 years of experience in a similar area, including:
- Managing medical device/combination product Change Controls
- Pre-filled-syringe device development, from early phase activities up to commercialization and production scale-up;
- Medical device quality assurance;
- DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects;
- Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive), ISO13485;
- Good communication and conflict solving skills;
- General understanding of pharmaceutical development ;
- General understanding of Human Factors Engineering and Risk management.
- General understanding of manufacturing
Support roll out of new change control process including training of personnel on process and systems
- Work with team members across sites to ensure quality documentation meeting all regulatory requirements
- Follow up with team members regarding actions to understand and remove roadblocks in completing changes
- Review and report KPIs to ensure timelines of change control actions
Excellent skills in English language are required.
Master degree in Science/Engineering or Mechanical Engineering or University level engineering education.