About This Role

This is an excellent growth opportunity with significant responsibility and ownership. iRhythm Technologies, Inc. is looking for a Senior Supplier Quality Engineer to join as a contributing member of our Quality team. This position is based ON SITE at our Cypress, CA location. Key responsibilities for this role include managing iRhythm suppliers, managing Supplier Quality Agreements, supplier qualifications, supplier audits, SCARs, and supplier product quality initiatives. In this role you will have responsibility for continuous improvements to the iRhythm Supplier Quality Program as well as an opportunity to participate in strategic initiatives. We are looking for a candidate with leadership capabilties and management aspirations. The ideal candidate must have experience working in medical device and electro-mechanical experience is preferred. In addition, the ideal candidate will also demonstrate the ability to address technical challenges with creative problem-solving techniques in a cross-functional environment working with Manufacturing, Supply Chain, and Engineering partners.

Responsibilities:

• Ensures suppliers deliver quality parts, materials, and services.
• Maintain and improve the Supplier Quality Program
• Represent the Supplier Quality Program in internal and external audits.
• Performs qualification audits of new suppliers to ensure good manufacturing practices (GMP) and quality standards are met.
• Performs Non-Conformance Investigation reports for Supplier related issues.
• Qualify new suppliers and new components.
• Continuously monitor supplier performance
• Support Updates 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.
• Performs Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components as part of NPD projects.
• Drive supplier corrective actions (SCAR) through timely completion and effectiveness
• Apply Quality Systems knowledge to execute project assignments.
• 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

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.
• 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
• Able to work on site in Cypress CA

Preferred Qualification/Experience

• Experience with injection molding and printed materials (packaging and labelling) is a plus.
• ISO13485 Lead Auditor certification is a plus.
• Experience with Purchased Part Approval Process (PPAP)

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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