דרוש/ה QA Engineer

תיאור המשרה:

We’re looking for a QA Engineer to support and strengthen our manufacturing quality. In this role, you’ll work closely with cross-functional teams, execute day-to-day quality activities on the manufacturing floor and help drive continuous improvement in a hands-on, fast-paced environment.
 LOCATION: Yokneam, Israel.
SCOPE & RESPONSIBILITIES

• Manage ECOs: conduct risk assessments, update relevant DMR s and carry out necessary IQ, OQ, PQ activities if required, finalization of implementation tasks.
• Manage DCOs in the PLM system: Write and update QA procedures to ensure compliance with quality standards and regulatory requirements.
• Manage NCR and CAPA processes: Lead, write and supervise the NCR and CAPA processes, ensuring timely and effective resolutions.
• Manage QA production activities: Provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality.
• Ensure Timely Resolution of Quality Issues: Promptly address all identified or assigned quality issues to prevent delays and maintain efficient operations.
• Participate in audits: Take part in internal and external audits, such as FDA inspections and notified body audits based on ISO13485, EUMDR, and MDSAP requirements.
• Manage Supplier quality: Manage supplier qualification and performance monitoring, including SCAR management, and support supplier audits.

• Bachelor of Science degree or Engineering.
• 3-5 years of experience in medical device QA (ISO 13485, MDSAP, FDA QSR 820).
• Internal auditor certification- an advantage
• Ability to work in dynamic and multi-interfaced surroundings, micro and macro vision.
• Strong attention to details and Self-learning ability.
• Ability to manage time and priorities and work under pressure.
• English - high level (both written and spoken).
• Excellent leadership and people management skills.
• Service oriented.
• Knowledge and practical experience in Priority – An advantage.