About This Role

iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 6 million patients and their doctors on a shorter path to what they both need – answers.

The Senior Manager, Software Quality will play a key role in delivering products and services of the highest quality and maintain regulatory compliance to applicable standards and regulatory requirements.

This role supports all global iRhythm sites and may require approximately 10% travel. The role may be remote or based in San Francisco, CA.

Responsibilities:

• Manage and lead a team of Software Quality Engineers focused on all aspects of software lifecycle quality assurance, testing, documentation and regulatory compliance related to iRhythm’s products and services.
• Lead the development and implementation of software quality process strategies, policies, and procedures in compliance with FDA regulations, ISO 13485, IEC 62304, IEC 82304 and other relevant standards.
• Provide expertise and guidance on FDA Part 820 Design Controls and other global regulatory requirements applicable to medical device software development.
• Ensure software development activities adhere to regulatory standards throughout the product lifecycle, including design, development, testing, and post-market surveillance.
• Support regulatory submissions and audits by providing documentation and evidence of compliance with applicable regulations and standards.
• Develop and maintain change control processes for software development, ensuring that changes are properly evaluated, documented, and implemented while maintaining regulatory compliance.
• Monitor and track changes to software requirements, design, and code, assessing their impact on product quality, safety, and effectiveness.
• Utilize project management skills to develop comprehensive R&D project plans for software development initiatives, including defining project scope, objectives, timelines, and resource requirement.
• Establish, implement and maintain the processes for development, testing, administration and maintenance of SaMD, ancillary software tools, non-product software and manufacturing firmware/software at iRhythm.
• Provide training, education and guidance to team members and stakeholders across the organization on SaMD, Software quality documentation and regulatory compliance.
• Ensure the products and services developed at iRhythm are delivered in an effective, efficient and compliant manner.
• Develop and maintain process interactions with the iRhythm Quality Management System to ensure compliance and oversight.
• Perform risk assessments and develop mitigation strategies to address software-related hazards and ensure patient safety.
• Conduct thorough reviews and audits of software development processes and deliverables to identify and resolve quality issues.
• Develop strong working relationships and synergy with the broader quality/compliance team, software development (systems) and product development teams.
• Oversee the design, implementation, and execution of software verification and validation activities to ensure software meets specified requirements and standards.
• Manage the CAPA process for software-related issues, including investigation, root cause analysis, corrective action planning, and effectiveness monitoring.
• Collaborate with cross-functional teams to address and resolve CAPA findings in a timely manner, ensuring continuous improvement of software quality and reliability.

Qualifications:

• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, or a related field; advanced degree preferred.
• Minimum of 10 years of experience in software quality assurance and process management within a regulated industry, preferably medical devices.
• Strong understanding of FDA regulations (e.g., 21 CFR Part 820), ISO 13485, IEC 62304, IEC 82304, ISO 14971 and other relevant quality standards.
• Proven experience working with Agile methodologies in large-scale dynamic environment, with a deep understanding of agile principles and practices.
• Proficiency in risk management methodologies and tools, including FMEA (Failure Mode and Effects Analysis) and risk assessment.
• Experience leading CAPA investigations and implementing effective corrective and preventive actions.
• Preferred experience with SaMD and/or AI-based devices.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Proven ability to develop and manage project plans, prioritize tasks, and meet deadlines in a fast-paced environment.
• Certification in quality management (e.g., ASQ Certified Quality Engineer) and project management (e.g., PMP) is a plus.
• Strong analytical skills and experience in interpreting and analyzing software quality metrics and performance data to drive continuous improvement initiatives.
• Working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDR requirements.

What’s In It For You

This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:

• emotional health support for you and your loved ones
• legal / financial / identity theft/ pet and child referral assistance
• paid parental leave, paid holidays, travel assistance for personal trips and PTO!

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes and so much more! 

FLSA Status: Exempt

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