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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