Quality Compliance Specialist II- Shockwave

Position Overview Johnson & Johnson is hiring a Quality Compliance Specialist II – Shockwave Medical in Santa Clara, CA. Responsibilities Perform Lot History Record (LHR) and Lot Release Testing (LRT) documentation reviews for 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 and follow‑up to ensure timely completion. Support Deviation (DA) activities, including documentation, tracking, and timely closure. Assist owners and cross‑functional teams with investigation and disposition documentation as applicable. Provide status updates and support data gathering for boards and reviews. 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 (NCR) as needed, including electronic transactions and routing. Compile data and prepare reports/presentations for periodic reviews of quality systems (e.g., NCRs, Deviations, Rework). Support internal and external audits by preparing and presenting role‑specific evidence (LHR/LRT, Deviations, Rework) and providing accurate responses to auditor questions. Interface with subject‑matter experts to obtain, clarify, and reconcile information within scope. Work cross‑functionally with other teams to compile and generate periodic reports to support quality systems activities. Assist in ensuring Quality Objectives are met during Management Reviews. Support company goals, policies, and procedures, QSR, and FDA regulations. Qualifications Bachelor’s degree and 2+ years of related experience in the medical device or other regulated industry. Experience supporting product release activities, including LHR and LRT documentation review. Experience supporting Deviation (DA) and Rework processes; NCR support experience is a plus. Experience supporting FDA/ISO audits (preparing and presenting role‑specific evidence). Strong ownership mindset for assigned projects/initiatives (drives work to closure, proactively removes barriers, escalates appropriately). Ability to compile, analyze, and trend quality data; create clear reports and presentations for stakeholders (e.g., Excel, PowerPoint). Competent technical/document writing skills and ability to follow QMS procedures (e.g., SOPs, test methods). Excellent written and verbal communication skills; ability to work cross‑functionally with Operations/Manufacturing, Quality, and other partners. Basic knowledge of cGMP, FDA 21CFR 820 QSR, and ISO 13485 (or equivalent Quality Systems). Proficiency with computer‑based applications (MS Word, MS Excel, PowerPoint). Strong time‑management skills and ability to multi‑task in a fast‑paced environment. Ability to work independently and/or as part of a team, demonstrating flexibility to changing requirements. EEO Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. #J-18808-Ljbffr 6947-SHOCKWAVE MEDICAL INC. Legal Entity