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Manager, QA R&D

Malta, Marsa 44800.00 EUR / Year · Job Posted March 01, 2026
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Job Description

As a Quality System Leader: develop, maintain and manage the R&D Site(s) Quality Management System to ensure compliance with the requirements of the customers, of the Health Authorities and the Corporation.

Job Responsibility

  • Ensure site compliance to applicable regulations and standards and maintain site certifications
  • Ensure Quality System processes are correctly implemented on site
  • Recommend, lead, and/or support projects for improvements to the quality system
  • Identify Key Quality Indicators to provide data for continuous improvement and potential escalation
  • Ensure site audit readiness for internal, external, and unannounced audits - Drive success in audits, compiling audit responses and tracking audit commitments
  • Support Supplier Quality responsibility for the R&D site, and participate in supplier audit, as needed
  • Implement and participate as auditor to the internal site audit program
  • Manage, identify, hire, develop and recognize the Quality System team
  • Ensure appropriate documentation is complete, correct, that the schedules of any reviews are met

Requirements

  • Degree in Engineering (or equivalent) and 8-10 years of experience in the area of Medical Device Quality and/or Regulatory
  • 5+ years team manager experience
  • Demonstrates leadership skills and ability to work independently
  • Working knowledge of ISO 13485:2016
  • Problem Solving – Apply DMAIC and statistical techniques to address issues and investigations
  • Resourceful and independent - Applies organizational and technical knowledge to move teams through issues
  • Recognized as a Quality System expert by peers and other design site personnel
  • Demonstrated success in delivering results

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Competitive benefits
  • Discretionary bonuses
  • Long-term incentive

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