[Remote] Senior Quality Systems Engineer, Quality Events at iRhythm Technologies

United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s Degree or the equivalent quality/regulatory experience
Minimum of 5 years of experience in a Quality or Regulatory related role
Minimum of 3 years of experience with Corrective Action and Preventative Action (CAPA) and Nonconformance (NC) activities within a medical device or equivalent healthcare company
Deep understanding of the CAPA and NC system and associated regulatory requirements
Previous experience in Issue Escalation, including Field Risk Assessment (FRA) and Health Hazard Evaluation
Previous experience in a medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD/MDR
Strong investigational and problem-solving skills
Demonstrates Project Management abilities to lead and manage several projects, meet deadlines and use critical thinking skills to solve problems effectively
Must build rapport across functional teams within the organization and have the ability to work comfortably at all levels within the organization
Attention to detail and timeliness are critical
Excellent communication (verbal and written) and interpersonal skills required
Basic statistical methods including trend analysis

Responsibilities

Ensure the CAPA and NC system is compliant with U.S. and applicable international standards/regulations, including ISO 13485, ISO 14971, and EU MDR requirements
Partner with CAPA and NC owners and stakeholders on assessing issue descriptions and ensuring containment, investigation, root cause analysis, correction, corrective and preventive actions, and effectiveness checks are appropriate, robust, and timely
Partner with FRA leaders on FRA activities to ensure compliance to the process and timely execution
Train and mentor CAPA and NC owners in all required elements and best practices, including use of the eQMS tool
Represent Issue program, system and individual CAPA, NC and/or FRA records during regulatory and internal audits
Maintain the quality and compliance of Issue Escalation system records to ensure audit-readiness for internal and external quality system audits
Engage in continuous improvement of the Issue Escalation program by identifying opportunities and recommending actions

Skills

Key technologies and capabilities for this role

CAPANonconformanceRoot Cause AnalysisISO 13485ISO 14971EU MDRField Risk AssessmentHealth Hazard EvaluationQuality SystemsRegulatory Compliance

Questions & Answers

Common questions about this position

What qualifications are required for the Senior Quality Systems Engineer role?

Candidates need a Bachelor’s Degree or equivalent quality/regulatory experience, a minimum of 5 years in a Quality or Regulatory role, at least 3 years with CAPA and Nonconformance activities in medical devices or healthcare, deep understanding of CAPA/NC systems and regulations, and prior experience in Issue Escalation including Field Risk Assessment and Health Hazard Evaluation.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What does iRhythm's company culture emphasize?

iRhythm emphasizes collaboration, innovation, continuous reimagination of possibilities, thinking big, moving fast, and a commitment to putting patients first while improving lives.

What makes a strong candidate for this Quality Systems Engineer position?

A strong candidate will have hands-on experience with CAPA, NC, and Issue Escalation processes in medical devices, knowledge of standards like ISO 13485, ISO 14971, and EU MDR, and the ability to collaborate cross-functionally, train others, and drive continuous improvement.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free