עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
Our headquarters are in Caesarea, Israel, with business operations in more than 100 countries worldwide. Operations Quality Leadership
* Lead, mentor, and professionally develop the Operations Quality Team.
* Set quality standards, inspection controls, and defectprevention methodologies on the production floor. MRB, NC & CAPA Management
* Lead MRB decision-making and material disposition.
* Own NC/CAPA processes: investigation quality, rootcause analysis, corrective & preventive action closure. Quality Systems & Compliance
* Maintain and improve SOPs, work instructions, and quality procedures related to operations.
* Own risk assessments (pFMEA), risk surveys, and operational quality KPIs. Support for External Audits
* Act as a key operational quality representative during Notified Body, MDSAP, ISO 13485, FDA, and customer audits.
* Ensure operational readiness: documentation integrity, calibration status, inspection records, training, material traceability, and MRB completeness.
* Drive audit response actions, containment, and long-term corrective actions in coordination with RA/ QA. Supplier Quality & Supplier Audits
* Lead supplier quality oversight with Supply Chain.
* Conduct supplier qualification and performance audits (ISO 9001/13485-based).
* Manage supplier NCs, SCARs, incoming defects, and continuous improvement activities.
* Align incoming inspection plans with supplier capability and risk level. Complaint Investigation Support
* Partner with Global Service for field complaint investigations, ensuring fast and accurate operational rootcause analysis and corrective actions. Operational Excellence & Projects Lead quality improvement initiatives, yield enhancement, process stabilization, etc
* Previous experience in management (+3 team members).
* Confident decisionmaker; high professional authority, Coachable.
* Ability to coach investigators and elevate quality discipline across Operations.
* Strong crossfunctional collaboration: Production, Engineering, Supply Chain, Service.
* B.Sc. in Engineering, Quality Engineering, Materials, Biotechnology, or equivalent technical field.
* ISO 13485 & MDSA.
* Internal Auditor.
* RootCause Analysis methodologies.
* CAPA & risk management.
* Supplier/Lead Auditor certification Experience working with:
* Middle size manufacturing sites including multiple cross functions.
* Global medical device companies.
* ISO 13485, FDA QSR, MDSAP, MDR.
* NC/CAPA methodologies.
* MRB processes.
* Supplier quality management.
* Risk tools: pFMEA, control plans, hazard analysis.
* Experience supporting external audits and conducting internal or supplier audits.
* data -oriented: comfortable with dashboards, trends, and statistical thinking.
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
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