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QMS Project Manager Tel Aviv Description:
Vectorious has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in-human clinical study, we have successfully implanted our sensory device in patients across Europe, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease.
Now, we are looking for an OMS Project Manager to join our team
What will you do?:
- Executing Document Control activities according to company’s procedure. Defining structure of the documentation system.
- Tracks, monitors, maintains, and controls QA processes related activities from compliance, data gathering and process integrity perspective in accordance with company’s procedures: ECO, employee’s trainings, CAPA, Quality Internal and External Audits NCs and observations, Quality System Management Review preparation and follow-up.
- Gather, analyze, and document process and product M&M data for trend or immediate action identification.
- Maintain and follow-up Quality Plans Objectives
- Support any other Quality System Functions as required
What do you need to bring with you?:
- Relevant engineering degree (e.g., Mechanical, Electrical or Biotechnology engineering) – must
- Minimum 3 years of QA/QMS experience in pharmaceutical, medical device or biotech industry - Must (ISO 13485 – an advantage)
- Participation in NB and FDA Audits as a SME
- Excellent English writing, reading, and understanding, speaking