Quality Assurance Engineer

Job Title: Quality Assurance Engineer
Department: Regulatory Affairs / Quality Assurance
Reports To: QA Manager
Position Scope: Full-Time
Location: Caesarea

About XACT Robotics

XACT Robotics is a rapidly growing medical robotics startup company. Our technology is designed to be compatible with a broad range of imaging modalities, capable of delivering various instruments to a desired target for a wide range of clinical applications and indications.

Working at XACT Robotics allows you to exercise your creativity. We encourage our employees to develop themselves, grow their careers and execute meaningful technologies that make an impact on the lives of patients.

If you have passion, drive, and a winning spirit, don`t miss this opportunity.

Main Responsibilities

  • Responsible for supplier quality including Full Turnkey suppliers, suppliers’ qualification and assessment, SCAR, contract manufacturers and other service providers. Perform audits at suppliers and work with them on enhancing the quality of products provided to XACT Robotics.
  • Designs the measurement techniques, audits and data reports which evaluate the attainment of the quality objectives and the efficiency of the quality system.
  • The Quality Engineer has significant contribution to processes of regulatory accreditation including preparing for audits / inspections, maintaining a constant state of audit-ready, compliance with standards, and promoting a culture of safety.
  • Participates in CAPA and other committee meetings where Quality Data is periodically reviewed striving to continuous improvement.
  • Participates in Risk Management / Risk Analysis activities ensuring that relevant risks and hazards are identified and that adequate mitigations are considered and defined. Use risk-based approach to enable proportional response.
  • Lead day to day manufacturing quality engineering activities, such as product quality documentation, ECO’s, non-conformities & FAI. Allocate risks and implement solutions.
  • Collect, analyze and interpret statistical data, perform analyses and provide reports as required.
  • Actively involved in the NPI process, Implementation of Quality plans, KPI’s.
  • Review and approval of ECO/MCO/ATP, ATR/deviations.

Qualifications & Requirements

  • Bachelor’s degree required in Engineering or other related life science field.
  • Minimum of 5 years progressive experience in Medical Device industry dealing with compliant quality system, system’s improvement and accreditation standards.
  • Knowledges: high knowledge of manufacturing processes (mechanical, electronics) IPC610/IPC620, SMT, CNC.
  • Capable of leading various assignments including ones characterized with higher level of complexity.
  • Can resolve professional challenges independently with minimal guidance from his supervisor. Can efficiently draw meaningful conclusions and implement lessons learned.
  • Self-motivated.

 

 

Contact Us

XACT ACE™ Robotic System is the world’s first and only hands-free robotic system that combines advanced image-based procedure planning and navigation with robotic instrument insertion and non-linear steering capabilities.