85 applicants

Company

Original Job Post

iRhythm Technologies, Inc. · 2 days ago

Senior Manager, Software Quality Assurance

United States

Full-time

Hybrid

Senior Level

$158K/yr - $200K/yr

10+ years exp

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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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Software quality assuranceProcess managementFDA regulationsISO 13485IEC 62304IEC 82304ISO 14971Agile methodologiesRisk managementFMEACAPA investigationsProject managementAnalyzing software quality metricsContinuous improvement initiativesFDA 21 CFR 820European Union MDR requirementsCommunicationInterpersonalCollaborationAnalyticalProblem-solvingSaMDAI-based devicesQuality ManagementASQ Certified Quality EngineerPMP

Required

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.

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.

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.

Preferred

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.

Benefits

Medical insurance

Dental insurance

Vision insurance

Health Savings Account contributions

Cafeteria plan benefits (FSA, dependent care FSA, commute reimbursement)

Travel reimbursement for medical care

Basic life insurance

Short/long term disability insurance

Emotional health support

Legal/financial/identity theft/pet and child referral assistance

Paid parental leave

Paid holidays

Travel assistance for personal trips

401(k) with company match

Employee Stock Purchase Plan

Pet insurance discount

Access to LinkedIn Learning classes

Company

iRhythm Technologies, Inc.

Glassdoor

2.9

iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease.

Founded in 2006

San Francisco, California, USA

1,001-5,000 employees

http://www.irhythmtech.com

H1B Sponsorship

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