About This Role

iRhythm is seeking a highly skilled and experienced Senior Quality Engineer to join our quality team during this pivotal phase of our growth journey. As a Senior New Product Introduction (NPI) Quality Engineer, you will hold a critical position within our NPI Quality Engineering group, providing indispensable support across both our product development and manufacturing areas.

Your responsibilities include offering comprehensive quality engineering support to iRhythm's development and manufacturing teams, with a specialized emphasis on product and process design transfers. The role will encompass a broad spectrum of activities, including facilitating new product launches, overseeing site/process expansions, managing significant and minor product/process modifications, and driving strategic manufacturing-led initiatives including international expansions.

This position is based at our manufacturing facility located in Cypress, CA, and is a full-time opportunity.

Responsibilities:

• Actively 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 (including reviewing and approving protocols)
• Actively participate in execution oversite 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 development and continuous improvement of applicable procedures to ensure the compliance with applicable standards and industry practices
• Produce technical reports to support quality assurance investigations as needed
• Participates 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 years 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%

Preferred Qualifications:

• The ideal candidate has electro-mechanical experience
• Six-Sigma Certification preferred
• Experience with Lean Manufacturing preferred

What's In It For You

This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:

• emotional health support for you and your loved ones
• legal / financial / identity theft/ pet and child referral assistance
• paid parental leave, paid holidays, travel assistance for personal trips and PTO!

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes and so much more! 

FLSA Status: Exempt

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