Senior Quality Assurance Engineer

5 days ago

Cypress, California, United States iRhythm Technologies Full time

About This Role

This is an exciting opportunity to join iRhythm Technologies as a Senior Supplier Quality Engineer. As a key member of our Quality team, you will be responsible for managing our suppliers, ensuring they meet our quality standards, and driving continuous improvements to our Supplier Quality Program.

Key Responsibilities

  • Manage iRhythm suppliers and ensure they deliver quality parts, materials, and services.
  • Maintain and improve the Supplier Quality Program.
  • Represent the Supplier Quality Program in internal and external audits.
  • Perform qualification audits of new suppliers to ensure good manufacturing practices (GMP) and quality standards are met.
  • Perform Non-Conformance Investigation reports for Supplier related issues.
  • Qualify new suppliers and new components.
  • Continuously monitor supplier performance.
  • Support updates to supplier files to ensure compliance.
  • Define Receiving Inspection requirements as required and associated test method validation.
  • Provide technical quality engineering support to Manufacturing, Engineering, and Product Development projects.

Requirements

  • Bachelor's Degree in an applied science or engineering field.
  • Minimum of 5 years of experience in Quality Assurance or Manufacturing of class II/III or equivalent experience.
  • Minimum of 3 years of experience within or related to Supplier Quality Management.
  • Demonstrated competency with 21 CFR 820, ISO 13485, ISO 14971, AS9100.
  • Exceptional problem-solving and organizational skills.
  • Experience in using Microsoft Excel, Word, and Visio.
  • Experience in root cause analysis. Six-Sigma Certification preferred. Experience with Lean Manufacturing preferred.
  • Experience with Internal and External Audits.
  • Exceptional cross-functional communication skills and strong attention to detail.

What's In It For You

This is a regular full-time position with a competitive compensation package, excellent benefits, and opportunities for growth and development.

About iRhythm Technologies

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. We combine wearable biosensors and cloud-based data analytics with powerful proprietary algorithms to distill data from millions of heartbeats into clinically actionable information.

Through a relentless focus on patient care, our vision is to deliver better data, better insights, and better health for all.

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