חזרה ללוח
Quality Engineer
סטפ אפ קריירה
מיקום
שרון
תחום
מכשור רפואי
בכירות
ביניים
היקף משרה
משרה מלאה
גודל חברה
קטנה (11-50)
סוג תפקיד
איכות
תיאור המשרה
This role is responsible for ensuring compliance, quality, and operational excellence throughout the development and manufacturing of Class III medical devices.
Responsibilities
• Ensure compliance with FDA regulations, ISO 13485/14971, EU MDR, and applicable standards.
• Lead and manage CAPA, complaints handling, standards gap analysis, internal audits, and management reviews.
• Oversee and support MRB activities, change control, process controls, validations (PV, EQ), pFMEA, risk management, and statistical process monitoring.
• Prepare for and support external and internal audits (FDA, ISO, Notified Bodies).
• Collaborate with cross-functional teams and train staff on QA best practices.
Location: Sharon district, Israel (Hybrid)
דרישות התפקיד
• Bachelor’s degree in Engineering, Science, or a related field.
• 5+ years of QA experience in Class III medical device environments.
• In-depth knowledge of FDA 21 CFR Part 820, ISO 13485/14971, and EU MDR.
• Experience conducting investigations, identifying root causes, leading corrective actions, and applying risk management and statistical tools.
• Strong written and verbal communication skills, with excellent analytical and problem-solving abilities.
• Auditor certification and experience with ERP/eQMS systems are an advantage.