Quality Compliance Specialist II- Shockwave

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Quality Compliance Specialist II - Shockwave Medica l to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview In compliance with Quality System Regulations (QSR) and FDA requirements, the Quality Compliance Specialist II supports product release and quality system activities by performing Lot History Record (LHR) and Lot Release Testing (LRT) documentation reviews to enable product release decisions. Performs work under supervision and follows established procedures to ensure documentation is complete, accurate, and aligned to procedures and release requirements; coordinates resolution of record discrepancies; and supports internal and external audits by preparing and presenting role-specific evidence. The position also supports quality record workflows including Deviations (DAs), Rework, and Nonconforming Records (NCRs), and collaborates cross-functionally to compile and trend quality data and generate periodic reports. Essential Job Functions Perform Lot History Record (LHR) and Lot Release Testing (LRT) documentation reviews to support product release decisions. Review LHR/LRT documentation for completeness, accuracy, and alignment to procedures and release requirements. Coordinate resolution of record discrepancies, including documentation updates as needed, and follow up to drive timely completion. Support Deviation (DA) activities, including documentation, tracking, and timely closure. Support DA record documentation, tracking, and closure to meet timeliness expectations. Assist owners and cross-functional teams with investigation and disposition documentation, as applicable. Provide status updates and support data gathering for boards and reviews, as required. Support Rework activities, including documentation, tracking, and timely closure of Rework records. Coordinate with Operations/Manufacturing and Quality partners to ensure rework documentation supports product disposition and release. Support Nonconforming Records (NCRs) as needed, including NCR electronic transactions and routing. Compile data and prepare reports/presentations for periodic reviews of quality systems (e.g., NCRs, Deviations (DAs), Rework), as needed. Support internal and external audits by preparing and presenting role-specific evidence (LHR/LRT product release, Deviations (DAs), and Rework) and providing accurate responses to auditor questions. Interface with Subject Matter Experts (SMEs) as needed to obtain, clarify, and reconcile information within scope. Work cross-functionally with other teams to compile and generate periodic reports in a timely manner to support quality systems activities. Work cross-functionally with other teams in tracking and ensuring Quality Objectives are met during Management Reviews Support company goals and objectives, policies, and procedures, QSR, and FDA r

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