דרושים » הנדסה » מנהל /ת פרויקטים הנדסיים לחברה ביוטכנולוגית מצליחה

A medical device company in the Hashron area is looking for a Quality Assurance Specialist to join our growing team. In this role, you will be responsible for implementing and supporting document control processes and general quality management system (QMS) activities. This position is crucial to maintaining Magentas high quality and regulatory compliance standards.

Reports to: QA Manager

Responsibilities

Operate and maintain the Electronic Quality Management system (eQMS).
Oversee and support all Document Control activities, ensuring timely and accurate processing.
Manage Document Change Orders (DCOs) and Engineering Change Orders (ECOs).
Maintain and update the Device History Files (DHF) and Device Master Records (DMR).
Collaborate with cross-functional teams to ensure compliance with internal procedures and regulatory requirements

Ensure compliance with regulatory requirements and industry standards.
 Write, review, and approve QA documents, including SOPs, specifications, procedures, templates, and forms.
Manage and lead quality events and deviations that occur during the product manufacturing stages.
Performing risk assessments and evaluations
Managing CAPAs, Change Control action items, training execution, and effectiveness checks
Investigate customer complaints related to quality issues
Support internal and external audits