A medical device SU in Netanya is seeking to hire a Quality Design Assurance Engineer for our QA team.
As a Design Assurance Engineer, you will lead all quality elements of Design Controls and product DHF for new product introductions and sustaining/design projects.
Quality responsibility to verify that the design and development process follows the procedures and plans.
Work closely with R D and TEST teams to support regulatory requirements by creating, reviewing, and providing quality and compliance input to the design and development process, deliverables, and requirements.
Participation in project meetings to review and help update clear and concise user requirements, product specifications, plans, verification and validation studies, risk management files, and other relevant design control deliverables.
Quality responsibility for transferring new products
Requirements: medical device industry must.
At least 1 year of experience as a design control engineer (preferred).
A Bachelor of Science in Engineering, Sciences, or a related field must.
Familiar with statistical techniques used in verification and validation processes must.
Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards must.
Strong analytical and problem-solving skills, with keen attention to detail.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
Proficient use of standard MS Office applications.
Fluent in English (oral and written).
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