Main responsibilities are:
- Experience shall include validation of Computer Systems, investigations, and change control in a medical device manufacturing environment.
- Work with Enterprise Architecture and IT Platform leads in both Functional IT
- Knowledge of FDA 21CFR Part 11/820, ISO13485 and other applicable regulations.
- Experience at writing/executing validation plans, IQ, OQ and PQ qualification protocols and reports for computer systems
- Develop and manage a high performance team of computer system validation analyst.
10 years+ of computer validation experience in the medical device manufacturing industry or equivalent. English Advanced. Bachelor's degree in sciences, engineering or IT. Strong knowledge in Medical Device industry: FDA, 21CFR...