Join a team dedicated to supporting the crucial mission of improving health outcomes.
At Merative, you can apply your skills and grow new ones with colleagues who have deep expertise in health and technology.
Merative provides data, analytics and software for the health industry. Our clients include providers, health plans, employers, life sciences companies and governments around the world.
With industry-leading products and focused innovation, we help customers improve decision-making and performance so that together, we drive real progress in health.
Learn more at merative.com
This role can be based in either Hartland, WI or Mississauga, Ontario.
The Sr Manager, Quality & Continuous Improvement is responsible for driving continuous improvement and delivering a Quality Management System (QMS) that enables the success of Merge Healthcare’s business while maintaining compliance.
This is a leadership role that requires in-depth knowledge of quality management systems for regulated and non-regulated software in the healthcare technology sector.
This role requires leadership and collaboration skills, with the ability to influence change and drive improvement at all levels of the organization.
Essential Job Duties
Quality Management Systems
Deliver an efficient and effective Quality Management System in conformance with applicable regulations, standards, and industry guidance
To enable Merge Healthcare to conduct business in target geographies, including USA, Canada, EU, and UK.
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.
Advise and coach employees on the application of the QMS, as necessary.
Continuous Improvement
Foster a culture of excellence, collaboration, and continuous improvement across the organization.
Collaborate with cross-functional business and functional leaders
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.
Basic Qualifications
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%
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