Change Control and Configuration Management Specialist
מעבר למשרות נוספות וויופוינט השמות
פורסם לפני 1 ימים
- בית שמש, ירושלים, מודיעין מכבים רעות, שוהם
- משרה מלאה
- לא צוין שכר
תיאור המשרה:
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.
• Implement and monitor Configuration Management (CM) practices to ensure product
configurations are accurately defined, documented, and traceable.
• Maintain revision control of engineering drawings, specifications, BOMs, and other controlled
documents in Priority, PDM and eQMS systems.
• Collaborate with R&D, Manufacturing, Operations, Suppliers, Quality, and Regulatory teams to
ensure changes are effectively communicated and implemented.
• Support internal and external audits by providing documentation and demonstrating adherence to
configuration and changing control processes.
• Develop and maintain SOPs, Work Instructions, and training materials related to change and
configuration management.
• Generate metrics and reports on changing cycle times, backlog, and process compliance for
management review
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.
• Implement and monitor Configuration Management (CM) practices to ensure product
configurations are accurately defined, documented, and traceable.
• Maintain revision control of engineering drawings, specifications, BOMs, and other controlled
documents in Priority, PDM and eQMS systems.
• Collaborate with R&D, Manufacturing, Operations, Suppliers, Quality, and Regulatory teams to
ensure changes are effectively communicated and implemented.
• Support internal and external audits by providing documentation and demonstrating adherence to
configuration and changing control processes.
• Develop and maintain SOPs, Work Instructions, and training materials related to change and
configuration management.
• Generate metrics and reports on changing cycle times, backlog, and process compliance for
management review
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.
• Excellent written and verbal communication skills in Hebrew and English (mostly written skills).
• 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.
• Excellent written and verbal communication skills in Hebrew and English (mostly written skills).
מעבר למשרות דומות בתחומים:
משרה מספר 9831501
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