דרושים » ביוטק » מהנדס /הנדסאי כימיה לתפקיד טכני בתחום השרות לחברה יבואנית מובילה בתחום ציוד למעבדות!

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

Join a growing biotech company in the final stages of FDA submission!
Were looking for a hands-on Validation engineer with strong experience in writing and executing validation protocols and reports. This is a key role reporting directly to the Engineering Manager.

Responsibilities:
Write and execute validation protocols (IQ/OQ/PQ)
Prepare comprehensive validation documentation including plans, protocols, reports, deviations, and CAPAs
Collaborate with cross-functional teams: Engineering, QA, RA, and Manufacturing
Support internal and external audits, including FDA readiness
Maintain and improve validation procedures in compliance with GMP, FDA, and ISO standards