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Quality Management Systems Lead

4 weeks ago

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

Drive Quality Excellence at 2105 Merge Canada Holdco Unlimited Liability Company

As a key member of our team, you will be responsible for delivering a Quality Management System (QMS) that enables the success of our business while maintaining compliance. This leadership role requires in-depth knowledge of quality management systems for regulated and non-regulated software in the healthcare technology sector.

Key Responsibilities

  • Quality Management Systems
    • Deliver an efficient and effective Quality Management System in conformance with applicable regulations, standards, and industry guidance.
    • Provide leadership for internal, external, and supplier audits to identify areas for improvement, and implement corrective and preventive actions.
    • Proactively review and evaluate evolving regulations, standards, and industry guidance to maintain alignment of the organization with the state of the art.
    • Deliver effective training and education for employees to ensure awareness and understanding of QMS processes applicable to their role.
    • Plan and execute quality assurance processes, including Audit, CAPA, Change Control, Computer System Validation, Document/Record Control, Supplier Management, and Training.
  • Continuous Improvement
    • Foster a culture of excellence, collaboration, and continuous improvement across the organization.
    • Collaborate with cross-functional business and functional leaders to drive continuous improvement initiatives to enhance the efficiency and effectiveness of the QMS.
    • Define, collect, analyze, and track quality metrics to monitor performance and provide recommendations for improvement.
    • Generate reports and recommendations for improvement as input to Management Reviews at prescribed intervals.
  • Leadership
    • Lead and mentor a high-performing team of direct reports, fostering a culture of collaboration and continuous learning.
    • Establish clear performance expectations and goals for the team, providing regular feedback, coaching, and recognition.

Requirements

  • Proven experience (7+ years) in the healthcare technology or life sciences industry, preferably with a focus on Software as a Medical Device (SaMD).
  • Exceptional problem-solving and decision-making skills.
  • Strong organization and management skills, with the ability to prioritize, multi-task, and delegate to achieve established goals and objectives.
  • Excellent interpersonal, communication, and presentation skills.
  • In-depth understanding of applicable standards, including ISO13485, ISO14971, and IEC62304.
  • Knowledge of applicable regulations preferred: 21 CFR Part 820 US Quality Management System Regulation SOR/98-282 Canada Medical Device Regulation, a 2017/745 EU Medical Device Regulation.
  • Understanding of Software as a Medical Device (SaMD) and software development lifecycles, including agile methods.
  • Familiarity with technology applications, such as Jira, Confluence, TrackWise Digital, and Microsoft 365.
  • At least 5 years management experience in a medium to large-sized organization.
  • Track record of building and leading high-performance teams.
  • Ability to work independently with minimal supervision in a team setting.
  • Bachelor's degree in a scientific or technical discipline required.
  • Certified ISO13485 Lead Auditor preferred.

Work Environment

Office environment, or remote work-from-home. Travel: ~10%.