Description
We are looking for a
Medical device Technical Expert - Risk management (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Lead specific risk management activities within projects as agreed with project leaders
- Facilitate development and completion of risk assessments
- Ensure timely completion and quality of the assigned risk management files
- Manage the overall risk management program of the packaging and device development activities within the team
- Ensure compliance with ISO 14971 in all development projects
- Supervise risk management activities in all development projects
- Harmonize the medical device risk management outputs across all development projects
- Conduct and provide guidance on the use of risk analysis for use, products, components and processes
- Ensure compliance with regulatory and normative guidelines, focusing on medical device risk management
- Work with device development team to incorporate and complete risk management during all design phases for new and/or product enhancements
- Apply FDA CFR 820, ISO13485 and ISO 14971 risk management in assigned projects
Your qualifications
- Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education
- Excellent English skills are required
- Proficiency in German is advantageous
- Other language skills, e.g. French, are also advantageous
- Experience as medical device risk management team leader
- Experience in managing risk management files
- Good technical knowledge of parenteral packaging and medical devices
- Awareness of Human Factors Engineering
- Experience in development and documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects
Skills:
- Quality manager
- R&D scientist
Keywords: Scientist R&D