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Quality Assurance Manager
1 month ago
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.
- 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.
- Leadership
- Lead and mentor a high-performing team of direct reports, fostering a culture of collaboration and continuous learning.
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.
Technical 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.
Supervisory Skills
- 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.
Education Requirements
- 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%.
