Quality Systems Engineer Lead at iRhythm Technologies

San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s Degree or equivalent experience
Minimum of 8 years of experience in a Quality or Regulatory role, preferably in medical devices, with at least 6 years of experience working in the Quality System
Direct experience in Quality System processes and project management
Strong leadership presence with excellent communication (verbal and written) and interpersonal skills
Experience managing team projects, including experience as an active contributor on projects with scheduled deliverables
Ability to manage complexity, analytical, and resource management on a global basis
Strong working knowledge of GxPs, ISO 13485 and 14971, and FDA and EU MDR regulations
Strong analytical skills with demonstrated ability to troubleshoot complex process issues
Attention to detail and timeliness
Basic knowledge of statistical techniques
Well-versed with Quality System Regulations (FDA 21 CFR Part 820, ISO 13485, EU MDR 2017/745, UK MDR 2002, Japan MHLW/PMDA QMS Ordinance)

Responsibilities

Lead projects related to improving the Quality System
Collaborate on the implementation of strategies for Quality improvement processes
Interpret and communicate trends
Work with stakeholders and other business leaders to identify opportunities for improvement based on data insights
Identify detailed customer requirements, constraints, and assumptions with stakeholders to establish project deliverables
Drive the identification, assessment, monitoring, and resolution of project risks
Manage QMS activities to support the achievement of project milestones
Partner with key stakeholders to define actions and plans to develop and maintain a high-performing, scalable, and compliant Quality System
Translate data and trends into actions to drive business decisions
Help identify product trends and drive actionable insights
Extract and format data from various systems per the respective processes
Develop and optimize methods to visualize data (Tableau dashboards, charts, presentations, etc.)
Work together with teams across all levels of the organization
Aid in coordination and support of e-QMS upgrades, software tool upgrades, and improvement initiatives in relation to Quality System IT infrastructure
Lead and/or support the investigation of complex quality issues
Lead workstream integration and remediation of Quality System policies and procedures as assigned
Conduct gap assessments and implement necessary process changes with subject matter experts
Engage in continuous improvement activities by identifying opportunities and recommending improvements to processes across iRhythm
Other related duties as may be assigned

Skills

Quality Management System

QMS

FDA 21 CFR Part 820

ISO 13485

EU MDR

UK MDR

Japan MHLW/PMDA

Statistical Techniques

Project Management

Risk Management

Regulatory Compliance

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters

2006Year Founded

$102.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Mental Health Support

Hybrid Work Options

Pet Insurance

Risks

Increased competition from emerging cardiac monitoring technologies threatens market share.

FDA warning letter may lead to regulatory scrutiny and potential fines.

Shareholder investigation could result in legal challenges and financial liabilities.

Differentiation

Zio Patch offers up to 14 days of uninterrupted cardiac monitoring.

iRhythm's Zio Patch is the smallest and least conspicuous cardiac diagnostic device.

The company provides data analysis services for actionable insights from Zio Patch data.

Upsides

Wearable health tech market growth aligns with iRhythm's business model.

Telehealth expansion increases demand for remote monitoring solutions like Zio Patch.

AI integration enhances arrhythmia detection accuracy in iRhythm's Zio Patch.

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