For a fast-growing medical device company focused on developing, manufacturing,
and selling innovative devices for endovascular interventional procedures
We are seeking a skilled and detail-oriented QA Engineer to join our team
Quality Engineer Scope & Responsibilities:
Manage ECOs including risk assessment, DMR updates and validation activities (IQ/OQ/PQ)
Handle DCOs in PLM system and update QA procedures
Lead NCR/CAPA processes to ensure effective resolution
Support production with quality oversight and deviation management
Address quality issues in a timely manner
Participate in regulatory audits (FDA, ISO 13485, EU MDR, MDSAP)
LOCATION: Yokneam
Requirements: Bachelor of Science degree or Engineering.
2-5 years of experience in medical device QA (ISO 13485, 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.
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