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QA Engineer at Mego Afek

Kiryat Bialik, Haifa District, Israel -

Full Time

Start Date

Immediate

Expiry Date

26 Sep, 26

Salary

0.0

Posted On

28 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Oversight, Risk Management, Design Control, Design Verification and Validation, Change Control, DHF Maintenance, ISO 13485, ISO 14971, Medical Device Compliance, Technical Documentation Review, ECO/ECR Approval, MS Office

Industry

Medical Equipment Manufacturing

Description

The Quality Engineer will provide quality oversight for new product development, sustaining engineering changes, risk management activities, and maintenance of Design History File (DHF) documentation while ensuring compliance with applicable regulations and standards. Ensure compliance with Design Control requirements and internal procedures. Review and monitor of design planning, design reviews, design V&V, and design transfer activities for compliance. Ensure traceability between user requirements, design inputs, design outputs, risk controls, V&V activities. Review and approve ECOs, ECRs for risk, and compliance with QMS and standards. Verify that changes are properly documented, approved, implemented, and closed according to established procedures. Requirements Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Quality Engineering, or related technical/medical discipline. Certified Quality Engineer (CQE) or equivalent certification – advantage At least 5 years of Quality Engineering experience in the medical device industry. Experience with relevant standards (ISO13485, ISO 14971). Experience supporting Design Control and Change Control processes. Experience reviewing DHF, DMR, V&V protocols and reports, and other technical documentation. Fluent English (written and spoken). Proficiency in MS-OFFICE

Responsibilities

The Quality Engineer provides quality oversight for new product development and sustaining engineering changes while maintaining Design History File documentation. They ensure compliance with Design Control requirements, internal procedures, and applicable regulatory standards.