|Quality Validation and Verification specialist – leading Medical device company – Switzerland |
Leading Californian based Medical device Company, looking to dramatically expand its European presence in preparation for taking a medical drug delivery device to market in Switzerland.
As a result, they’re looking to make a number of expert Validation and Verification appointments to optimise the quality management systems.
The validation and verification expert will lead and manage the activities related to Medical Drug delivery device to ensure that the final product meet the intended use. Including:
- End-to-End System Test Requirements within validation
- Review & approve supplier test plans, protocols and validation reports
- Develop and execute validation and verification protocols
- Plan and implement quality assurance and quality control for all test activities related to the validation project
You must have the following:
- Masters’ degree (or equivalent) in Mechanical engineering or Electronic engineering
- Training to software development life cycle, preferably in the medical device domain (21 CFR 820, IEC 62304, FDA software guidelines ISO 13485 and ISO 11608)
- Experience in working within a regulated medical device development environment, particularly based on the FDA Quality System Regulation and ISO 13485.
- Knowledge of Medical drug delivery device with embedded software in validation
- Languages - English, knowledge of French or / and German is a plus
If you are interested in this exceptional opportunity, please apply immediately. Only those who cover all the requirements will be contacted.
- Travel expenses covered
- 6 months contract with likelihood of extension
- Large investments into Switzerland site, in preparation for launch of exciting new medical delivery device.
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