Senior Quality Assurance Engineer

(1129) QA Engineer - Medical Devices

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.

This position is open to all candidates.