Beschreibung
Risk Manager SpecialistLocation: Zürich Area
Period: asap for 6 months
RISK MANAGEMENT/QUALITY ENGINEER
Overall Responsibilities:
- Improvement of Risk Management documentation to the Product Risk Management Process of:
- Risk Management Plan
- Design & Clinical Risk Management
- Risk Management Report
- ISO14971 & FMEAs, PFMEAs
Functional Experience Requirements
- Strong background in Product Risk Management with experience in creation, review, and approval of risk management documentation (DFMEAs and PFMEAs)
- Two or more years' experience in the design and development of medical devices or Pharmaceuticals preferred.
- Strong analytical skills.
- Practical experience in a medical device Regulatory Environment, preparing Design Dossier Submissions and preparation of Technical Files is beneficial.
- Knowledge of European Medical Device regulations is preferred; in addition, knowledge of US Medical device regulations is beneficial.
Required Degree/Certificates:
- BS in Engineering (or science) required.
Competencies:
- Proficient in Microsoft Office (Excel, Word, etc.).
- Ability to work as a member of a team in a timeline-driven environment with limited supervision is
- Being detail-oriented while having the ability to handle multiple ongoing projects/tasks is required.
Strong Team player Specific Languages:
- Fluent (spoken and written) in English.
- Basics in German would be required.
If this or similar positions are of interest to you, please do not hesitate to get in contact in with me in order to discuss potential opportunities on the Medical Device Market in Switzerland.
Bets Regards
Sabina Keel
you can send your CV directly to