Senior Quality Engineer - New Product Introduction
- Cypress, CA
*Must be located in Cypress, CA. We are offering relocation assistance for the right candidate.*
iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias 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 arrhythmias. 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.
About this role:
This is an excellent growth opportunity with significant responsibility and ownership. iRhythm Technologies, Inc. is looking for a Sr. Quality Engineer to join as a contributing member to our Product Quality team. The Sr. QE will provide hands-on engineering support to iRhythm’s manufacturing environment with a focus on New Product Introduction. This role will handle Quality focused tasks, from product inception through product launch and maintenance. The Quality Engineer will oversee all Quality aspects of Design Control Transfers. The ideal candidate has electro-mechanical experience and a demonstrated ability to address technical challenges with creative problem solving techniques.
- Provide engineering guidance for Design Control Transfer deliverables including Receiving Inspection criteria development, Validation strategy planning, sampling plan alignment, BOM development, Work Instruction approvals, failure mode analysis, and Production and Process Controls oversite
- Provide technical Quality Engineering support to Manufacturing and Product Development
- Provide Quality Engineering support within Supplier Quality
- Participate in Risk Management activities including pFMEA development
- Assist in identifying, processing, and investigating non-conforming product
- Oversee Process Validations including IQ/OQ/PQs, TMVs
- Assist in performing manufacturing related complaint investigations to determine root cause
- Apply statistical tools to analyze data and drive problem resolution
- Produce technical reports to support quality assurance investigations
- Perform other quality-related duties as assigned
- Drive and own CAPA investigations
- 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 2 years of experience within Design Control
- Demonstrated competency with 21 CFR 820, ISO 13485, ISO 14971
- 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.
- Exceptional cross-functional communication skills and strong attention to detail
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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