Change Control and Configuration Management Specialist
מעבר למשרות נוספות וויופוינט השמות
פורסם לפני 1 ימים
- בית שמש, ירושלים, לוד, מודיעין מכבים רעות, שוהם
- משרה מלאה
- לא צוין שכר
תיאור המשרה:
The Change Control and Configuration Management Specialist is responsible for overseeing product
and document changes throughout their lifecycle to ensure compliance with regulatory requirements
(FDA 21 CFR Part 820, ISO 13485, and EU MDR). This role ensures that all changes to product design,
manufacturing processes, software, and documentation are properly evaluated, documented, and
implemented in a controlled and traceable manner.
Key Responsibilities:
• Manage and maintain the company’s Change Control System for product design, manufacturing,
software, and quality documentation.
• Coordinate cross-functional Change Review Board (CRB) meetings to evaluate and approve change
requests.
• Ensure all change documentation (e.g., ECRs, ECOs, DHF, DMR updates) meets regulatory and
internal quality system requirements.
and document changes throughout their lifecycle to ensure compliance with regulatory requirements
(FDA 21 CFR Part 820, ISO 13485, and EU MDR). This role ensures that all changes to product design,
manufacturing processes, software, and documentation are properly evaluated, documented, and
implemented in a controlled and traceable manner.
Key Responsibilities:
• Manage and maintain the company’s Change Control System for product design, manufacturing,
software, and quality documentation.
• Coordinate cross-functional Change Review Board (CRB) meetings to evaluate and approve change
requests.
• Ensure all change documentation (e.g., ECRs, ECOs, DHF, DMR updates) meets regulatory and
internal quality system requirements.
דרישות המשרה:
Education: Bachelor’s degree in Engineering, Quality, or related scientific discipline.
• Experience: 3–5 years of experience in change control and configuration management in a
manufacturing of multidisciplinary products, in a quality system environment (ISO 9001 at
minimum) preferable in a medical device company.
• Experience supporting product development, NPI and commercial products in the aspect of change
and configuration management.
• Familiar with:
o FDA QMSR
o ISO 13485
o ISO 14971 (Risk Management)
• Technical Skills: Experience with Priority, PLM and eQMS. Proficiency with MS Office and document
management systems.
• Strong attention to detail, organizational skills, and ability to work in a cross-functional
environment.
• Experience: 3–5 years of experience in change control and configuration management in a
manufacturing of multidisciplinary products, in a quality system environment (ISO 9001 at
minimum) preferable in a medical device company.
• Experience supporting product development, NPI and commercial products in the aspect of change
and configuration management.
• Familiar with:
o FDA QMSR
o ISO 13485
o ISO 14971 (Risk Management)
• Technical Skills: Experience with Priority, PLM and eQMS. Proficiency with MS Office and document
management systems.
• Strong attention to detail, organizational skills, and ability to work in a cross-functional
environment.
מעבר למשרות דומות בתחומים:
משרה מספר 9843252
הגדילו את החשיפה שלכם למגייסים עם מנוי ProJobs
אלפי מגייסים מחפשים אתכם במאגר הפרופילים בג'וב מאסטר, הגדילו את החשיפה שלכם עד פי 4 באמצעות מנוי ProJobs
ניתן לבטל את המנוי בכל עת