Sr Manager, Quality Engineering (SaMD)

Essential Job Duties 

• Plans, directs, and implements the design quality aspects of Merge Healthcare’s design and development of new medical imaging solutions, with a focus on software quality/reliability, risk management (patient safety and cybersecurity), and usability. 

• Provides expertise and guidance in interpreting applicable regulations and industry standards. 

• Ensures development programs are appropriately planned and resourced for design quality. 

• Proactively identifies, prioritizes, communicates, and resolves quality, safety, and compliance issues. 

• Provides oversight, training, and coaching in the application of Quality Management System (QMS) processes to ensure successful adoption and implementation by product development teams. 

• Supports development of deliverables for regulatory submissions. 

• Assists with post-market activities, including Health Hazard Evaluations (HHEs), field corrections, and post-market surveillance, as necessary. 

• Participates in internal and external audits and inspections, as necessary. 

• Drives continuous improvement of Merge Healthcare’s processes to advance quality, safety, and compliance. 

• Provides oversight for the development and improvement of quality programs, systems, processes, and procedures to ensure compliance with applicable regulation and standards. 

• Fosters a culture of excellence, collaboration, and continuous improvement across the organization. 

• Leads and mentors a high-performing team of direct reports, fostering a culture of collaboration and continuous learning. 

• Establishes clear performance expectations and goals for the team, providing regular feedback, coaching, and recognition. 

• Collaborates with cross-functional business and functional leaders to drive continuous improvement initiatives to enhance the efficiency and effectiveness of the QMS.  

• Defines, collects, analyzes, and tracks quality metrics to monitor performance and provide recommendations for improvement. 

• Generate reports and recommendations for improvement as input to Management Reviews at prescribed intervals. 

Basic Qualifications  

• Proven experience (10+ years) in healthcare technology, life sciences, or similar regulated industries, preferably with a focus on Software as a Medical Device (SaMD). 

• Exceptional collaboration, problem-solving, critical-thinking, 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, IEC62304, and IEC62366. 

• Knowledge of applicable regulations preferred: 

• 21 CFR Part 820 US Quality Management System Regulation 

• SOR/98-282 Canada Medical Device Regulation  

• 2017/745 EU Medical Device Regulation 

• In-depth understanding of Software as a Medical Device (SaMD) and software development lifecycles, including agile methods. 

• Familiarity with technology applications, such as Jira, Aha!, Jama, and Microsoft 365.  

Supervisory Skills 

• At least 5 years’ technical leadership or 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, or equivalent experience. 

• Experience with agile development and cloud solutions preferred. 

Work Environment 

The work environment characteristics here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Office environment, or remote work-from-home. 

• Travel: ~10%