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A Medical device company,Innovative and successful, in Netanya area is looking for an Experienced Operations Quality Assurance Specialist to join the QA Operations group and support the 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.

Join a leading Medical Device Company as a Director of Quality to be responsible for leading the Quality Management system in compliance with ISO 13485, 21 CFR Part 820, MDSAP and other applicable regulatory requirements. This role oversees quality across the product lifecycle, including design control, operations, and post-market activities.
Key Responsibilities:
Lead implementation and oversight of design control processes for new and modified devices.
Manage and ensure quality in operations: production, final product release, incoming inspection activities, process validation and supplier quality.
Manage configuration and doc control process.
Own and maintain the quality management system, including internal audits, CAPA, complaints, and management review.
Prepare for and lead external audits (e.g. notified bodies, FDA).