Design Assurance Engineer – Growing MedTech Company
- Perform technical reviews of design files and labelling, participating in design reviews and providing leadership for design activities.
- Review design risk management documents.
- Support test development and validation activities.
- Provide approval for record, tests, validation, reports and design technical files.
- Act as lead for product design transfers and developing the validation strategy.
- Support external audits from notified bodies and FDA audits.
- Degree in engineering or science with 2 years’ experience working in a medical device or pharmaceutical environment.
- Must have an ISO13485 or FDA QS regulatory experience.
- Software validation experience preferable but must have excellent data analysis skills.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
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