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CAPA Analyst I

Company: Abbott
Location: Alameda
Posted on: May 3, 2021

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. Thats why were focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology. Our location in Alameda, CA currently has an opportunity for a CAPA Analyst I. WHAT YOULL DO Progresses all elements of the nonconformance and CAPA process steps.
Works closely and provides guidance to other functional areas with the use of investigational tools, to determine the root cause of any nonconformity, ensure that CAPA plans address root causes, and ensure that CA/PAs are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems.
Supports management review and post market surveillance reports Works to ensure that actions are on time, thorough, complete, meet the needs of the business and customers, and that required standards and/or procedural requirements are met.
Is an effective member of a multi-functional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct. Responsibilities: Evaluates and progress the timely completion of CAPA system activities, including initiation, investigation, corrections, corrective and preventive actions, and effectiveness checks. Manages timelines, sets milestones, and manages the timely competition of all activities related to non-conformances, potential non-conformances, and/or deviations. Drive the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the non-conformance. Facilitate cross functional problem solving by using root cause analysis tools such as fishbone diagram, process flow charts, interviews, is/is not. Write CAPA reports to ensure documentation is complete, clear, and concise. Conduct data analysis on department metrics, compile management review slides, compiles post market surveillance slides. Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements. Maintains the effectiveness of the quality records to ensure audit-readiness for internal and external quality system audits within the area. Supports the attainment of ADC goals and objectives. EDUCATION AND EXPERIENCE YOULL BRING RequiredAssociate degree or equivalent experience (i.e. minimum of 2 years work experience in the medical device/pharma/biotech industry). Minimum of two (2) years of experience working in a regulated environment or experience performing investigations. Attention to detail to ensure accuracy of work that forms part of the Quality System documentation. Good written and oral communication skills to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization. Able to work independently with some supervision. Preferred Bachelor degree preferred. Knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 is preferred. Strong project management skills, PMP certification is a plus ASQ CQE certification is a plus Training or certification to Six Sigma is a plus WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email

Keywords: Abbott, Alameda , CAPA Analyst I, Other , Alameda, California

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