תיאור המשרה:
we are looking for experienced QA/RA specialist
•Responsible for establishing and maintaining the customer’s quality management system, and training the customer to meet established quality standards and release top of the line products
•Responsible for establishing and maintaining customer’s quality management system and activities including Development, performance and oversight of all routine QA activities according to a regulations compliant QMS.
•Ensuring compliance with regulatory and company procedure requirements.
•Experience in regulations (MDSAP, FDA, CE(MDR), ISO13485) ensuring proper processes and policies, obtain necessary regulatory approvals and maintain regulatory compliance.
•Experience in preparing SW documentation including associate Cyber docs.
•Experience in preparing V&V structures for medical devices.
•Experience with files submissions around the world, implementation of the regulatory requirements of – FDA, CE (MDR), Israel, China etc. Supporting R&D in creation of documentation (DHF)
•Analysis of failures and root cause analysis, CAPA on non-conformities and customer complaints.
•Ensuring that manufacturing processes comply with standards at both national and international level.
•Responsible for establishing and maintaining the customer’s quality management system, and training the customer to meet established quality standards and release top of the line products
•Responsible for establishing and maintaining customer’s quality management system and activities including Development, performance and oversight of all routine QA activities according to a regulations compliant QMS.
•Ensuring compliance with regulatory and company procedure requirements.
•Experience in regulations (MDSAP, FDA, CE(MDR), ISO13485) ensuring proper processes and policies, obtain necessary regulatory approvals and maintain regulatory compliance.
•Experience in preparing SW documentation including associate Cyber docs.
•Experience in preparing V&V structures for medical devices.
•Experience with files submissions around the world, implementation of the regulatory requirements of – FDA, CE (MDR), Israel, China etc. Supporting R&D in creation of documentation (DHF)
•Analysis of failures and root cause analysis, CAPA on non-conformities and customer complaints.
•Ensuring that manufacturing processes comply with standards at both national and international level.
דרישות המשרה:
•At least 5 years of experience in Quality and Regulation function at Medical Devices company or as a consultant;
•5+ years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards
•Experience in SW regulation (SMD, SaMD) and related standards.
•Experience in software Validation and Verification.
•Knowledge of GDPR and HIPAA requirements – advantage
•BS/BA in engineering or science discipline. Certificate in quality assurance is a plus.
•Detail oriented
•Good communication skills, both verbal and written
•Excellent English reading, writing and oral communication skills
•Hybrid work
•5+ years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards
•Experience in SW regulation (SMD, SaMD) and related standards.
•Experience in software Validation and Verification.
•Knowledge of GDPR and HIPAA requirements – advantage
•BS/BA in engineering or science discipline. Certificate in quality assurance is a plus.
•Detail oriented
•Good communication skills, both verbal and written
•Excellent English reading, writing and oral communication skills
•Hybrid work
מעבר למשרות דומות בתחומים:
משרה מספר 9650115
בלעדי לג'וב מאסטר
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כלומר פרטי המשרה וההתקשרות עם הגורם המגייס ידועים אך ורק לג'וב מאסטר.
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