Senior Manager of Quality and Compliance

3 weeks ago


Mississauga, Ontario, Canada 2105 Merge Canada Holdco Unlimited Liability Company Full time

Exciting Opportunity at Merative

We are seeking a highly skilled Senior Manager of Quality and Compliance to join our dynamic team at 2105 Merge Canada Holdco Unlimited Liability Company. As a leading provider of data, analytics, and software for the health industry, we serve clients worldwide and are dedicated to driving real progress in health outcomes.

Position: Senior Manager, Quality & Continuous Improvement

Key Responsibilities:

  • Quality Management Systems
    • Develop and maintain an efficient Quality Management System to ensure compliance with regulations and industry standards.
    • Lead internal and external audits to identify areas for improvement.
    • Provide training and support to employees on QMS processes.
    • Implement quality assurance processes such as Audit, CAPA, and Supplier Management.
  • Continuous Improvement
    • Promote a culture of excellence and collaboration within the organization.
    • Drive initiatives to enhance the efficiency of the QMS.
    • Collect and analyze quality metrics to monitor performance.
  • Leadership
    • Mentor and lead a high-performing team, setting clear performance expectations.
    • Provide feedback, coaching, and recognition to team members.

Requirements:

  • 7+ years of experience in healthcare technology or life sciences.
  • Strong problem-solving and decision-making skills.
  • Excellent interpersonal and communication skills.
  • Bachelor's degree in a scientific or technical discipline.

Technical Skills:

  • Knowledge of ISO13485, ISO14971, and IEC62304 standards.
  • Familiarity with FDA and EU regulations.
  • Understanding of Software as a Medical Device and agile development.
  • Experience with technology applications like Jira and Confluence.

Work Environment:

  • Office environment or remote work-from-home options available.
  • Travel required approximately 10% of the time.


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