Sr. Quality Engineer – CAPA

Quality Systems Engineer – CAPA

Join iRhythm, a pioneering digital healthcare company, and play a vital role in ensuring the quality and compliance of our life-changing solutions. As a Quality Systems Engineer specializing in CAPA (Corrective Action and Preventive Action), you will be instrumental in maintaining and improving our issue escalation processes, impacting product and process quality and regulatory compliance globally.

About the Role

This is an exciting opportunity to champion cross-functional collaboration, continuous improvement, and unwavering compliance within our organization. You’ll be a key resource for CAPA, Nonconformance (NC), and Field Risk Assessment (FRA) owners, offering training, guidance, and expert review of investigations and improvement phases. Your expertise will directly influence the quality of our products, the efficiency of our processes, and our adherence to regulatory requirements.

Key Responsibilities

• Guarantee the CAPA and NC system adheres to all relevant U.S. and international standards and regulations, including ISO 13485, ISO 14971, and EU MDR requirements.
• Collaborate with CAPA and NC stakeholders to assess issue descriptions, ensuring containment, thorough investigation, effective root cause analysis, appropriate corrections, proactive corrective and preventive actions, and timely effectiveness checks.
• Partner with FRA leaders to ensure compliance with the FRA process and timely execution of activities.
• Provide expert training and mentorship to CAPA and NC owners on all required elements and best practices, including the effective use of our eQMS tool.
• Represent the Issue program, system, and individual CAPA, NC, and/or FRA records during regulatory and internal audits.
• Maintain impeccable quality and compliance of Issue Escalation system records, ensuring audit-readiness for both internal and external quality system audits.
• Proactively engage in continuous improvement of the Issue Escalation program, identifying opportunities for optimization and recommending actionable solutions.

What You Bring to the Table

• Bachelor’s Degree or equivalent experience in quality and/or regulatory affairs.
• Minimum of 5 years of experience in a Quality or Regulatory related role within a medical device or healthcare setting.
• At least 3 years of direct experience with Corrective Action and Preventive Action (CAPA) and Nonconformance activities.
• A deep and comprehensive understanding of CAPA and NC systems and associated regulatory requirements.
• Proven experience in Issue Escalation, including Field Risk Assessment and Health Hazard Evaluation.
• Working knowledge of ISO 13485, FDA 21 CFR 820, and European Union MDD/MDR, particularly within the medical device industry.
• Exceptional investigational and problem-solving abilities.
• Demonstrated project management skills to effectively lead and manage multiple projects, meet deadlines, and apply critical thinking to solve complex problems.
• Excellent interpersonal and communication skills (both written and verbal), with the ability to build rapport across functional teams and interact comfortably at all levels of the organization.
• Exceptional attention to detail and a strong commitment to timeliness.
• Familiarity with basic statistical methods, including trend analysis.

Location

This is a Remote position based in the US.

Compensation

The estimated pay range for this role is $96,000.00 – $125,000.00, and will be commensurate with experience and location.

About iRhythm

iRhythm is revolutionizing digital healthcare by creating trusted solutions that detect, predict, and prevent disease. By combining wearable biosensors, cloud-based data analytics, and proprietary algorithms, we transform millions of heartbeats into clinically actionable information. Join us in our mission to deliver better data, better insights, and better health for all. Make iRhythm your path forward!

Zio, the heart monitor that changed the game.