QA/RA specialist
חסוי
פורסם לפני 10 ימים
- בנימינה-גבעת עדה
- משרה מלאה
- לא צוין שכר
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), ISO, etc.) ensuring the proper processes and policies, obtain necessary regulatory approvals and maintain regulatory compliance.
• Experience with perform registration products in markets around the world, implementation of the regulatory requirements of – FDA, CE (MDR), Israel, China etc.Supporting R&D in creation of documentation (DHF)
•Writing management and technical reports.
•Analysis of failures and root cause analysis, corrective and preventive actions to respond to non-conformities and customer complaints.
•Coordinate Company Training and implementation as required by the Quality management system.
•Ensuring that manufacturing processes comply with standards at both national and international level.
•Interface with Regulations, R&D, Operations and Product Management to implement appropriate verification activities and documentation supporting release of products
•Leading quality initiatives with operations to improve manufacturing processes and product quality.
•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), ISO, etc.) ensuring the proper processes and policies, obtain necessary regulatory approvals and maintain regulatory compliance.
• Experience with perform registration products in markets around the world, implementation of the regulatory requirements of – FDA, CE (MDR), Israel, China etc.Supporting R&D in creation of documentation (DHF)
•Writing management and technical reports.
•Analysis of failures and root cause analysis, corrective and preventive actions to respond to non-conformities and customer complaints.
•Coordinate Company Training and implementation as required by the Quality management system.
•Ensuring that manufacturing processes comply with standards at both national and international level.
•Interface with Regulations, R&D, Operations and Product Management to implement appropriate verification activities and documentation supporting release of products
•Leading quality initiatives with operations to improve manufacturing processes and product quality.
דרישות המשרה:
•At least 5 years of experience in Quality function in Medical Devices company;
•5+ years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards
•Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, 14971 (Risk Management) requirements, Medical Device Regulation (MDR) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
•Knowledge of GDPR and HIPAA requirements – advantage
•Experience in SW as a Medical Device and related standards - advantage.
•Experience in software Validation and Verification in FDA-compliant medical device industry – 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
•Work in the client’s offices
•5+ years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards
•Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, 14971 (Risk Management) requirements, Medical Device Regulation (MDR) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
•Knowledge of GDPR and HIPAA requirements – advantage
•Experience in SW as a Medical Device and related standards - advantage.
•Experience in software Validation and Verification in FDA-compliant medical device industry – 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
•Work in the client’s offices
מעבר למשרות דומות בתחומים:
משרה מספר 8619949
בלעדי לג'וב מאסטר
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זו משרה שהמעסיק החליט לפרסם אך ורק באתר ג'וב מאסטר,
כלומר פרטי המשרה וההתקשרות עם הגורם המגייס ידועים אך ורק לג'וב מאסטר.
חשוב להבהיר!
לאתרים שמעתיקים משרות ללא אבחנה מג'וב מאסטר, לרוב אין את פרטי ההתקשרות האמיתיים של איש/ת הקשר שאחראי על הגיוס בארגון למשרה זו.
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