עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!
במקום לחפש לבד בין מאות מודעות – תנו ל-Jobify לנתח את קורות החיים שלכם ולהציג לכם רק הזדמנויות שבאמת שוות את הזמן שלכם מתוך מאגר המשרות הגדול בישראל.
השימוש חינם, ללא עלות וללא הגבלה.
- קיסריה
-
- קיסריה
-
Description: Responsibility for the quality and regulatory framework in a medical device company. The position includes building and maintaining the Quality Management System (QMS), supporting development processes according to regulatory and standards requirements, supporting internal and external audits.
The candidate will be working on ensuring the company’s compliance with international standards and regulatory requirements, leading quality processes throughout the product lifecycle.
Key Responsibilities
· Establish, maintain, and continuously improve the Quality Management System in accordance with ISO
13485, FDA 21 CFR Part 820, MDR, and additional standards.
· Provide full support for Design Control processes,
· Document control, supplier qualification and evaluation
· Training and qualification activities
· Prepare and maintain Design History File (DHF), and SOPs.
· Oversee and approve change processes (ECR/ECO), product documentation, and change management
activities.
· Support R&D, V&V, and manufacturing teams in maintaining quality processes.
Support all production activities: Monitoring the production process, Equipment calibration and maintenance, Manage non-conformances (NC), handle CAPA activities, conduct internal audits, Management review, and prepare the organization for external audits.
Requirements
· Degree in Engineering or a related scientific discipline
· 3-4 Proven experience in QA roles within a Medical Device company – mandatory.
· Strong familiarity with standards: ISO 13485, ISO 14971, IEC 62304, FDA QMSR and EU MDR
· Solid understanding of development processes, V&V, and engineering documentation management.
· High-level English (professional reading and writing).
· Excellent organizational skills, accuracy, independence, and the ability to prioritize in a dynamic
environment.
· Strong interpersonal communication and ability to work with multiple internal and external
stakeholders.
· Experience supporting and managing audits
Advantages
· Experience in start-up environments or rapidly changing settings.
Reports to: QA/RA Lead
במקום לחפש לבד בין מאות מודעות – תנו ל-Jobify לנתח את קורות החיים שלכם ולהציג לכם רק הזדמנויות שבאמת שוות את הזמן שלכם מתוך מאגר המשרות הגדול בישראל.
השימוש חינם, ללא עלות וללא הגבלה.
