Sr Quality Engineer - CAPA Coordinator at iRhythm

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iRhythm

(40 open jobs)

iRhythm Technologies is redefining the standard for ambulatory cardiac monitoring.


Job title
Sr Quality Engineer - CAPA Coordinator
Job listing last updated at
Feb 11, 2021
Job listing location
San Francisco, CA or Cypress, CA
Job listing source
greenhouse
Job listing link
External link
Bay Area company location: 650 Townsend St # 500, San Francisco CA

Job description

*this role can be located in San Francisco or Cypress, CA

About iRhythm:

iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmia's are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmia's. iRhythm’s continuous ambulatory monitoring has already put over 3 million patients and their doctors on a shorter path to what they both need – answers.

As the iRhythm CAPA Coordinator 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. 

In iRhythm’s fast growing environment you will have the opportunity to enhance your technical skills and leadership competencies and advance your career. 

This role supports various U.S. and UK iRhythm sites and may require 15% travel.   

Responsibilities:

  • Ensure the iRhythm CAPA system is compliant to U.S. and applicable international standards / regulations, including ISO 13485, ISO 14971 and EU MDD/MDR requirements.
  • Chair cross-functional CAPA Board meetings, drive decision making, and follow through on outcomes
  • Work alongside CAPA owners and stakeholders on assessing issue descriptions and ensuring containment, root cause analysis, correction, corrective and preventive actions and effectiveness checks are appropriate, of high quality, 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.
  • Produce, analyze, and present trend metrics and reports and establish further actions as needed.
  • Engage in continuous improvement of the CAPA program by identifying opportunities and recommending actions.

Required Qualifications:

  • Bachelor’s Degree or equivalent quality/regulatory experience
  • Minimum of 5 years of experience in Quality or Regulatory related role.
  • Minimum of 2 years of experience with Corrective Action and Preventative Action activities, within a medical device or equivalent healthcare company.   
  • Must have deep understanding of CAPA system and associated regulatory requirements.
  • Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD/MDR
  • Minimum of 2 years of experience participating in regulatory audits in the front room and back room.
  • Strong investigational and problem solving skills
  • 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

 

What’s in it for you:

This is a full-time position with competitive compensation package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off.

iRhythm also provides additional benefits including 401K (w/ company match), employee stock purchase plan, annual organizational and cultural committee events and more!

FLSA Status: Exempt

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.

Make iRhythm your path forward.

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