Design Quality/ Assurance Engineer/ System Engineer JB-240

ישראל, צפון

תיאור המשרה

We are seeking a highly skilled and motivated Quality Assurance
Engineer with a strong background in technical writing and experience
within the medical device industry .
collaborate with cross-functional teams to establish, maintain’ and improve
the SDLC in accordance with relevant regulation (ISO 14971’ 21CFR820’ IEC 62304)
Develop and maintain detailed and accurate technical documentation
Ensure that design & Development documentation complies with industry standards and regulatory guidelines .
In charge of risk management according ISO 14971 and internal
SOPs .
stay up-to- date with relevant regulations and standards ensuring the company”s with changing requirements .
Ensure that validation activities are properly documented and meet regulatory expectations.

דרישות המשרה

Bechelor”s degree in Software Engineering or related field .

proven experience in quality assurance wivhing the medical device industry

strong technical writing skills with the ability to create clear concise technical documentation.

in-depth knowledge of medical device regulations’ including QSR and IEC 62304/82304.

Experience in risk management’ validation’ and verification processes.

Excellent analytical and problem-solving abilities .

Detail - oriented with focus on maintaining high standards of quality .

Effective communication and collaboration skills to work cross - functionally .

Certification in quality management (e.g, ASQ ,CQE ,CQMׁ )

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