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CAPA Process Analyst Lead

Company: Abbott Laboratories
Location: Santa Clara
Posted on: November 23, 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. ABOUT ABBOTT DIAGNOSTICS The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott---s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.Our pioneering technology spans the world of healthcare operations --- with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics. Our location in Santa Clara, CA currently has an opportunity for a CAPA Process Analyst Lead. WHAT YOU---LL DO The CAPA Process Analyst Lead provides leadership to the progression of CAPA investigations and to other activities of the CAPA Program.-- Leads and coaches cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CA/PAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems.-- Is an effective leader of multifunctional teams, in many occasions highly technical, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct and that the result of investigations and root cause analysis are technically sound and compliant with FDA and International regulations.

  • Provides operational leadership to the CAPA organization and to multifunctional teams composed of technical subject matter experts involved in the resolution of quality issues and continuous improvement of the quality system.
  • Leads the investigation of complex & highly technical quality issues to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
  • Must be able to communicate the work and decision-making process of investigations to a professional staff of engineers, scientists and to higher level management (DVPs, Directors & Managers).
  • Provides subject matter expertise, leadership, and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues.
  • Provides subject matter expertise on the CAPA process during internal and external inspections.
  • Evaluate and progress the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, CAPAs, deviations, and/or complaint investigations, as output from Quality System.
  • Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
  • Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
  • Produce and analyses trend metrics and reports and establishes further actions, as may be required.
  • Represents the CAPA organization on Interdivisional committees and Communities of Practice to drive continues improvement across the corporation.
  • Support the attainment of goals and objectives.
  • Accountable to the Quality Organization for achieving mutually agreed upon objectives.
  • Influence and visibility extend beyond the immediate organization and grade level, including international sites, Corporate and Divisional Management across Abbott.
  • Position involves interactions across multiple functional areas including operations, R&D, Marketing, Supply Chain, Quality and Regulatory.
  • Compliance activities are of the utmost importance to our business.
  • The CAPA System is a key inspection focus of worldwide regulators and auditors.
  • The system must be usable, simple, sustainable, and well maintained; Failure to comply with the primary objectives of this role can result in negative impact to the business such as observations, warning letters, de-certification, or product recalls.
  • Decisions and recommendations made by this position directly influence and impact the quality of marketed products and the effectiveness of the Quality System to applicable regulations. EDUCATION AND EXPERIENCE YOU---LL BRINGRequired --- CANNOT MODIFY
    • Bachelor---s degree (Technical or Scientific discipline preferred).--
    • Minimum of six (6) years of experience working in a regulated environment or experience performing investigations.--
    • Good working knowledge of FDA Quality System Regulations (QSR) and/or ISO13485.-- Knowledge of other industry standards affecting IVDs, and Medical Devices is preferred.
    • Working knowledge of investigational and Root Cause Analysis Techniques.
    • Ability to apply strategic, quality logic and excellent project management skills to investigation activities.
    • Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.
    • Excellent in technical writing and oral communication skills are required to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization.
    • Must be able to work independently. Preferred
      • Ability to work cross-functionally and within a team, as well as excellent oral communication skills to ensure effective communication within the team.
      • Problem solving and critical thinking skills in order to be able to analyze data, think critically and ability to draw conclusions from data.
      • Process based thinking and ability to analyze potential gaps in products or processes to determine root cause and corrective action.
      • Excellent technical writing skills and ability to bring complex information together in an organized and clear way.
      • Detail oriented with the ability to also make more broad connections based on information and details. 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 Learn more about our benefits that add real value to your life to help you live fully:-- www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at, on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Keywords: Abbott Laboratories, Santa Clara , CAPA Process Analyst Lead, Professions , Santa Clara, California

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