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QA Manager

Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS). We’re looking for an awesome QA Manager to join our core QA team that is reshaping MIS.

Responsibilities

  • Responsible for company’s product quality and reliability to meet or exceed customer expectations
  • Responsible for company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards worldwide.
  • Develop and execute quality design (design control) and quality assurance strategy for new product development and sustaining business activities.
  • In support of the quality system, provide effective leadership support, training and guidance to all company personnel.
  • Responsible for writing/guiding employees for writing all company procedures, specifications, instructions etc.
  • Maintenance of QA system.
  • Responsible on training system especially in quality issues.
  • Periodic reports to Top management about Quality issues and analysis MRB, CAPA, ECOs, internal and external audits, and product and process performance.
  • Leading MRB, CAPA, ECO committees.
  • Responsible on internal audits system.
  • Subcontractors’ approval, audits and control over their performances.
  • Establishment and control of traceability system of company product (DMR).
  • Responsible for approval of finished product release.
  • Responsible for customer complaint handling

Authorities:

Routine management of all above indicated areas

Experience Required:

Previous experience in the medical devices or life science and QA fields managements (management of QA systems)

 

 

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