עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!

במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.

מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.

חברה בתחום מחקר ופיתוח

יקנעם עילית

חברה בתחום מחקר ופיתוח

יקנעם עילית
מלאה

What Youll Do:
* Lead QA Operations: Oversee the teams activities, ensuring compliance with regulatory requirements and internal quality standards.
* Manage Change Controls: Supervise Engineering Change Orders (ECOs) and Document Change Orders (DCOs) to ensure proper risk assessment and implementation.
* Own NCR CAPA Processes: Drive Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA) to resolution.
* Support Production Quality: Work closely with manufacturing teams to maintain the highest quality in production and cleanroom environments.
* Ensure Compliance Audit Readiness: Participate in internal and external audits, including FDA inspections and ISO13485, EUMDR, and MDSAP audits.
* Proactively Solve Quality Issues: Address and resolve quality challenges efficiently to keep operations running smoothly.

Requirements:
* Education: B.Sc. in Science or Engineering.
* Experience: 5-7 years in medical device QA (ISO 13485, FDA QSR 820).
* Industry Knowledge: Experience in manufacturing and cleanroom environments.
* Certifications: Internal auditor certification.
* Skills: Strong leadership, attention to detail, self-learning ability, and ability to work under pressure.
* Languages: High-level English (written and spoken).
* Tech Skills: Experience with Priority ERP an advantage.

This position is open to all candidates.