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Engineering
QA Director / VP

Management
Tel Aviv

Vectorious Medical Technologies- a successful fast-paced medical-device startup, located in Tel-Aviv is looking for a QA director to oversee the quality department and the company’s QMS. The QA director will be the champion for driving a culture of quality throughout the company as well as defining and implementing a strategy to evolve the QMS to meet the changing needs of the business.

Responsibilities:

  • QMS direction, planning and leadership – ensure that the QMS meets the current needs of the business and that we plan for and manage QMS change; Bringing along stakeholders as the QMS evolves with business needs, markets and applications
  • ISO 9001 – Maintenance of a QMS that achieves ISO 9001:2015 certification and compliance with the Low voltage Directive and Medical Devices Directive, as well as compliance to any additional relevant standards, directives and regulations identified as a requirement for the business
  • Change Management – Driving transformational change as the company grows and evolves, the ability to engage and drive with the changes and scale / evolve the QMS accordingly in line with the business, is essential.
  • Document control – Experience of using a formal, version-controlled digital document management system in a QA context is essential. 
  • Processes –management of the Quality process, e.g. change control, CAPA, document control, supplier evaluation, etc.
  • Reporting – produce reports as required on the effectiveness of the QMS and other quality data to inform the management of the business
  • Documentation
  • Audits – management of internal, external and supplier audits.

Requirements:

  • At least 5 years of experience in QA/QMS management in Medical Devices, preferably implantables
  • Proven experience in designing and introducing quality systems meeting the requirements of ISO 13485
  • Experience with CE and FDA approvals
  • Superior organization and leadership skills
  • Team player with excellent interpersonal skills
  • Independent
  • Academic graduates in the field of Life Sciences or Engineering
  • Fluent verbal and written English
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