Senior Quality Assurance Engineer Position

5 days ago

Cypress, California, United States iRhythm Technologies, Inc. Full time
About iRhythm Technologies

iRhythm is a leading digital healthcare company that creates innovative solutions for disease detection, prediction, and prevention.

Job Overview

We are seeking an experienced Senior Quality Engineer to join our quality team at our manufacturing facility in Cypress, CA. This full-time position offers a competitive compensation package and excellent benefits, including medical, dental, and vision insurance, as well as opportunities for professional growth and development.

Responsibilities:
  • Participate as the Quality representative for projects within scope of this role.
  • Partner with Design Quality Engineering to ensure successful product transfer into manufacturing.
  • Apply engineering principles and quality regulations to drive validation and qualification executions during transfer phases for new product introductions and ongoing design control projects for product changes.
  • Actively participate in execution oversight for IQ/OQ/PQs, TMVs, engineering studies, and verifications.
  • Apply statistical knowledge to complete and analyze datasets, interpret results, and provide data-driven feedback to design and manufacturing teams.
  • Participate in the development and continuous improvement of applicable procedures to ensure compliance with applicable standards and industry practices.
  • Produce technical reports to support quality assurance investigations as needed.
  • Participate as NPI quality representative to associated risk documentation.
Required Qualifications:
  • 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.
  • At least 1 year of experience within Design Control.
  • Demonstrated competency with 21 CFR 820, ISO 13485, ISO 14971.
  • Strong organizational skills.
  • Experience in using Microsoft Excel, Word, and Visio.
  • Experience in root cause analysis.
  • Exceptional cross-functional communication skills and strong attention to detail.
  • Demonstrated ability to address technical challenges with creative problem-solving techniques.
  • Ability to travel up to 10%.
Benefits:
  • A competitive salary range of $95,800-$139,400 USD.
  • Excellent benefits, including medical, dental, and vision insurance.
  • Paid parental leave, paid holidays, and travel assistance for personal trips and PTO.
  • 401(k) plan with company match, Employee Stock Purchase Plan, pet insurance discount, and unlimited LinkedIn Learning classes.
  • Emotional health support, legal, financial, identity theft, pet, and child referral assistance.
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.

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