Senior Quality Engineer
4 weeks ago
iRhythm Technologies 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.
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 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 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%.
Preferred Qualifications:
The ideal candidate has electro-mechanical experience. Six-Sigma Certification preferred. Experience with Lean Manufacturing preferred.
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