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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.

חברה בתחום מש"א / הדרכה / השמה / בתי תוכנ

תל אביב יפו, פתח תקווה

חברה בתחום מש"א / הדרכה / השמה / בתי תוכנ

תל אביב יפו, פתח תקווה
מלאה

QA and Design Control Manager with proven experience in the medical devices industry to join our team and contribute to the effective maintenance of our (MDR) ISO13485 certified Quality Management system and move us ahead with the implementation of QMS that is compliant with FDA 21 CFR Part 820 regulation.
Job Responsibilities:
Responsible for managing or governing all QMS related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Management Reviews, Changes, Complaints handling, Recalls, data analysis, Risk management.
Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, and development until the post-marketing stages.
Assuring production line compliance and working closely with the QA at the contracted manufacturer.
Reports directly to the VP of Regulatory Affairs QA

Requirements:
A bachelors degree in engineering or a scientific discipline is required.
2+ years experience managing a team (with at least three members)
4-6 years of experience in Quality Assurance and medical devices.
Active participation and lead at Regulatory Audits (ISO13485, MDR).
Excellent familiarity and previous experience with Medical devices design control process per ISO13485 and 21 CFR Part 820.30
Previous experience with FDA 21 CFR Part 820 Quality system Regulation.
Experience with internal auditing-Advantage.
Familiar with standards and methodologies (e.g., ISO13485, ISO14971, IEC62304)- Advantage.
Possess excellent writing skills in English

This position is open to all candidates.