QA/RA Engineer in Medical Device industry

פתח תקווה |
5-6 שנים |
משרה מלאה
| לפני 18 שעות
תיאור משרה

Implement, maintain, and lead quality assurance activities across company’s R&D and manufacturing processes.
Manage risk management activities and contribute to continuous improvement initiatives.
Support internal and external audits (ISO 13485, 21 CFR 820, EU MDR).

דרישות התפקיד

• BSc in bio-medical / mechanical engineering, or a related technical field.
• At least 5 years of experience as QA/RA roles within the Medical Device industry.
• Hands-on experience in design control, risk management (ISO 14971), MRB, CAPA, batch release, ECO processes.
• Strong knowledge of medical device regulations and quality system standards.
• Fluent in English with strong writing skills.
• Collaborative team player, comfortable in a fast-paced, dynamic environment.

* משרה זו פונה לנשים וגברים כאחד.