· Bachelor degree in mechanical, electrical or similar engineering disiplines .
· 5+ Years of Quality Assurance experience in Medical device or other regulated industry.
· Understyanding of of applicable standards and regulations such as ISO 13485:2016 and 21 CFR 820.
· Understanding of process validation principles, including experience with master validation plans, installation qualifications, operational qualifications, process qualifications, and test method validations.
Experience in application of risk management techniques in supporting of design, production and post production activities.
Strong knowledge in CAPA, NCMR, RMA, Labeling, Rework and Batch release processes.
Ability to work effectively in a team environment with a diverse group of people.
· Fluent in English and Hebrew. Nice to Haves
· Certified Quality Engineer (CQE) or other similar Quality/Reilibility certifications
Experience in utilization of statistical techniques such design of experiments, hypothesis testing, SPC, etc. as part of Quality Engineering discipline.
Supplier Quality Engineering experience.
· Working knowledge of process improvement skills including Six Sigma, Lean Sigma.