Sr. Quality Manager, Design Assurance (SaMD)

The Sr. Quality Manager, Design Assurance (SaMD) is responsible for collaborating with cross-functional teams to promote the safety, quality, reliability, and compliance of Cleerly’s products and services. This role requires in-depth knowledge of the product development lifecycle, design controls, safety and cybersecurity risk management, and usability. This role requires a strong leader with exceptional collaboration, critical-thinking, and problem-solving skills, and the ability to drive cross-functional improvement at all levels of the organization. Strong SaMD experience is a must.

Essential Job Duties

• 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.

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
• 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.

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.

Salary: $180,000 - $274,000 TTC

 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). We hire employees anywhere within the United States and account for geography when determining base salary.