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Full-Time

Senior Manager

Software Quality Assurance

Confirmed live in the last 24 hours

iRhythm Technologies

iRhythm Technologies

1,001-5,000 employees

Ambulatory cardiac monitoring with wearable biosensors

Data & Analytics

Compensation Overview

$157.7k - $200.4kAnnually

Expert

Remote in USA

Category
QA & Testing
Quality Assurance
Required Skills
Agile
Management
Requirements
  • 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.
  • 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.
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.

The Zio service by iRhythm Technologies provides a next-generation ambulatory cardiac monitoring solution with single-use monitors, offering continuous and accurate data for up to 14 days. The technology utilizes wearable biosensors, cloud-based data analytics, and proprietary algorithms to distill data from millions of heartbeats into clinically actionable information.

Company Stage

IPO

Total Funding

$1.2B

Headquarters

San Francisco, California

Founded

2006

Growth & Insights
Headcount

6 month growth

4%

1 year growth

12%

2 year growth

32%