Sr. Quality Manager, Design Assurance (SaMD)

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Requirements:

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

Responsibilities:

• Plans, directs, and implements the design quality aspects of Cleerly’s design and development of software medical devices, 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.
• Analyzes device performance data to ensure compliance, develop processes for ongoing monitoring.
• Develops KPIs for Design Assurance and cascade to overall company OKRs.
• 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 Cleerly’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.
• 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.