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Role Description
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.
- Serve as an advocate for cross-functional collaboration, continuous improvement, and compliance.
- Drive excellent quality system CAPA, NC, and Issue Escalation process performance globally.
- Work closely with cross-functional CAPA, NC, and Field Risk Assessment (FRA) owners to provide training, guidance, and review of investigations and phases.
- 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.
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.
- 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.
- Ability to build rapport across functional teams within the organization and 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
Remote - US
Compensation
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location. Estimated Pay Range: $96,000.00 - $125,000.00
Company Description
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.
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