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Quality Assurance Manager
2 months ago
About the Role:
This is a leadership position that requires in-depth knowledge of quality management systems for regulated and non-regulated software in the healthcare technology sector. The successful candidate will be responsible for driving continuous improvement and delivering a Quality Management System (QMS) that enables the success of Merge Healthcare's business while maintaining compliance.
Key Responsibilities:- Quality Management Systems: Deliver an efficient and effective Quality Management System in conformance with applicable regulations, standards, and industry guidance.
- Continuous Improvement: Foster a culture of excellence, collaboration, and continuous improvement across the organization.
- 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.
About Us:
Merge Healthcare is 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.
