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SENIOR QUALITY SYSTEMS ENGINEER

Company: Disability Solutions
Location: Irvine
Posted on: April 3, 2024

Job Description:

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 Responsible for development, implementation and support of product escalation, Risk Management Board (RMB) and Quality Review Board (QRB) processes for BWI. DUTIES & RESPONSIBILITIES Under (e.g., limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: --- The individual will work under limited supervision to make compliance decisions to meet departmental and internal/external customer needs. --- She/he will coordinate Risk Management Board and Quality Review Board (QRB) activities - coordinate RMB activities, write meeting minutes, route and verify document review are also included duties. --- This individual will be responsible for reporting on escalation metrics to appropriate review boards such as Management Review, CAPA Review Board, Q&C Dashboard, etc. --- This individual will serve as a Team Member of the Product Escalation and Field Action Management Team in order to coordinate with the Field Corrective Action Lead to ensure hand off/transition of QRB actions and documentation that the Field Corrective Action Lead will use to report to regulatory authorities. --- The individual will facilitate root cause investigation, documentation, corrective action recommendations, and project management on RMBs; initiate and or approve document change orders as applicable for job; provide periodic reports, completes special assignments, assists manager as requested; and lead and participate in cross-franchise teams as directed by manager. --- Other responsibilities include, but are not limited to: coordinate and participate in special projects as assigned; act as backup support for Field Corrective Action Lead; and act as backup support for other CSS Product Escalation Quality Engineers. --- Responsible for communicating business related issues or opportunities to next management level --- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable --- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures --- Performs other duties assigned as needed

Keywords: Disability Solutions, Irvine , SENIOR QUALITY SYSTEMS ENGINEER, Other , Irvine, California

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