Sr. Quality Engineer - CAPA

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

About This Role:

As the Quality Systems Engineer - CAPA you will be responsible for maintaining robust Issue Escalation processes (CAPA, Nonconformance, and Field Risk Assessment/Health Hazard Evaluation) 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, NC, and Issue Escalation process performance globally. This role will work closely with cross-functional CAPA, NC and Field Risk Assessment (FRA) owners to provide training, guidance, and review of investigations and phases. In this role you will have the opportunity to impact product and process quality and regulatory compliance at iRhythm.

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.

Required Qualifications:

• 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 and Nonconformance activities within a medical device or equivalent healthcare company.
• Must have a deep understanding of the CAPA and NC system and associated regulatory requirements.
• Previous experience in Issue Escalation, including Field Risk Assessment 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.

Location:

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [email protected]

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121