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.
QHR
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QHR
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מלאה
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Responsible for generating, implementing and monitoring cross-functional quality processes, throughout life cycle of Alma Lasers company, subsidiaries and products
Review, edit and maintain all pre-established QMS policies including training, CAPAs, ECOs and MRBs
Implementation, upgrade and broadening of the companys SOPs
Manage companys effective training procedures and processes
Manage companys daily QA activities
Prepare and manage internal and external audits and certification tasks for CE, ISO 13485, MDSAP, FDA etc.
Work with international bodies such as Notified Bodies and regulatory consultants
Prepare and present management reviews
Manage QA goals to align with companys long-term strategy and regulatory requirements
Review and approve quality agreements
Lead validation activities related to product release procedures (e.g. sterilization, packaging, transportation)
Review, edit and maintain all pre-established QMS policies including training, CAPAs, ECOs and MRBs
Implementation, upgrade and broadening of the companys SOPs
Manage companys effective training procedures and processes
Manage companys daily QA activities
Prepare and manage internal and external audits and certification tasks for CE, ISO 13485, MDSAP, FDA etc.
Work with international bodies such as Notified Bodies and regulatory consultants
Prepare and present management reviews
Manage QA goals to align with companys long-term strategy and regulatory requirements
Review and approve quality agreements
Lead validation activities related to product release procedures (e.g. sterilization, packaging, transportation)
Requirements:
B.Sc. degree or higher in bio medical, life science, medicine, pharmacy, engineering, or a related discipline
Certification or other evidence of formal qualification in quality management (Advantage)
Knowledge in the field of medical devices with a minimum of eight (8) years of professional experience in QMS (ISO 13485) and regulatory affairs of medical devices, including at least three (3) years in implementing or managing quality systems in active medical devices class IIb or above preferred
Proven experience with CE, FDA, and ROW regulatory compliance
Experience with both Hardware, Software, and single-use components
Advantageous background in managing the transfer from R D to production and mature products
Excellent reading, writing, and communication skills in English and Hebrew
Strong reporting, teamwork, and time management skills
Ability to learn quickly, analyze problems.
This p
B.Sc. degree or higher in bio medical, life science, medicine, pharmacy, engineering, or a related discipline
Certification or other evidence of formal qualification in quality management (Advantage)
Knowledge in the field of medical devices with a minimum of eight (8) years of professional experience in QMS (ISO 13485) and regulatory affairs of medical devices, including at least three (3) years in implementing or managing quality systems in active medical devices class IIb or above preferred
Proven experience with CE, FDA, and ROW regulatory compliance
Experience with both Hardware, Software, and single-use components
Advantageous background in managing the transfer from R D to production and mature products
Excellent reading, writing, and communication skills in English and Hebrew
Strong reporting, teamwork, and time management skills
Ability to learn quickly, analyze problems.
This p
This position is open to all candidates.
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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