Support all V&V activities, including: process validation, software validation, Sterilization validation,
and Annual Validations: sealing machine, packaging, and product bioburden.
? Support all calibration process.
? Support supplier approval process.
? Support QA activities including non-conformity and etc.
? Assist project teams in product development activities including coordinating planning activities,
monitoring the release of documents and phase transition activities including design reviews and
verification and validation activities.
Bachelors Degree (BA/BS) in Engineering or Life Sciences discipline required.
Minimum four (4) years V&V Engineer of experience in Medical Devices or other health care
regulated industries required (ISO 13485:2016, CFR 820, MDSAP).
Experience with FDA, Health Canada, EU, Notified Body, and/or international regulators is
strongly preferred.
Ability to clearly communicate and write protocols and reports in English.
Experience in the design control process.
* משרה זו פונה לנשים וגברים כאחד.