Quality Assurance Leader
1 week ago
We are a leading provider of data, analytics, and software for the health industry. Our clients include providers, health plans, employers, life sciences companies, and governments around the world.
Job DescriptionThe Sr Manager, Quality & Continuous Improvement is responsible for driving continuous improvement and delivering a Quality Management System (QMS) that enables our business success 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.
This role involves leadership and collaboration skills, with the ability to influence change and drive improvement at all levels of the organization.
Main Responsibilities- Quality Management Systems: Deliver an efficient and effective Quality Management System in conformance with applicable regulations, standards, and industry guidance to enable our business operations in target geographies, including USA, Canada, EU, and UK.
- Continuous Improvement: Foster a culture of excellence, collaboration, and continuous improvement across the organization. Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the QMS.
- Leadership: Lead and mentor a high-performing team of direct reports, fostering a culture of collaboration and continuous learning.
- 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.
- Office environment, or remote work-from-home.
- Travel: ~10%.
The estimated annual salary for this position is between $130,000-$180,000 CAD based on location and industry standards.
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