Experienced Operations Quality Assurance Specialist

A Medical device company in the Netanya area is looking for an Experienced Operations Quality Assurance Specialist to join the QA Operations group and support a variety of activities related to QA Operations, such as:

Lead QA Operations activities with regards to verifications/validations for an FDA-reviewed complex, multidisciplinary, active investigational device.

Lead and perform the Engineering Change Order (ECO) process from risk analysis through protocol approval.

Verification, execution, and analysis of reports until FDA-ready.

Provide guidance to the R&D and Engineering teams on IQ/OQ/PV activities.

B.A. or B.S. degree in a technical discipline, such as Engineering or Science.

3-5 years of relevant experience in the medical device industry.

Previous experience with medical device verification/validations, ECOs, medical device statistics

Working knowledge of medical device international standards.

Ability to work independently with minimal work direction and in a cross-functional team environment.

Fluent in English with excellent writing skills, effective written and verbal communication skills.

Excellent computer skills, including a working knowledge of Microsoft Office applications.

Strong time management abilities to ensure timely task completion.

Detail-oriented.