Design Quality/ Assurance Engineer/ System Engineer
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 .
Responsibilities:
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 )
הערות נוספות
המשרה מיועדת לגברים ולנשים כאחד