Sr Quality Engineer - Corrective & Preventive Actions (CAPA)

Employment Type: Full time Location Type: Remote Salary:

Company Overview

Career-defining. Life-changing. At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career.

Boldly innovating to create trusted solutions that detect, predict, and prevent disease. Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care…Join Us Now!

At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm’s employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.

About This Role

As the Sr Quality Engineer - Corrective & Preventive Actions (CAPA), you will be responsible for maintaining a robust global CAPA process across iRhythm. You will serve as an advocate for cross-functional collaboration, continuous improvement, and compliance, with the responsibility of driving excellent quality system CAPA process performance globally. This role will work closely with cross-functional CAPA owners to provide training, guidance, and review of CAPA investigations and phases. In this role, you will have the opportunity to impact product and process quality and regulatory compliance at iRhythm.

Essential Duties and Responsibilities

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

Experience and Minimum Qualifications

• Education: Bachelor’s Degree or the equivalent quality/regulatory experience.
• 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 activities, within a medical device or equivalent healthcare company.

Knowledge, Skills and Abilities

• Must have a deep understanding of the CAPA system and associated regulatory requirements.
• 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.
• Basic statistical methods including trend analysis.

Work Environment / Other Requirements

• Work Location: Remote
• Travel: This role supports various U.S. and UK iRhythm sites and may require 15% travel.

What’s in it for you: