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CAPA Process Analyst II

Company: Experis
Location: Princeton
Posted on: September 24, 2022

Job Description:

Experis, a ManpowerGroup company, has an exciting contract opportunity with one of our key clients, a global medical devices and health care company that is engaged in the discovery, development, and manufacturer of medical equipment and healthcare products. Job Title: CAPA Process Analyst IILocation: Princeton, NJ.Duration: 06 months (with possible extension)Shift 1 st - 08:00 AM- 05:00 PM CAPA Process Analyst:

  • Progresses investigations and other activities through the CAPA program.
  • Leads 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.
  • Ensures that actions are on time, thorough, complete, and meet the needs of the business and customers, and that required standards and/or procedural requirements are met.
  • Leads a multifunctional team, ensuring that all communications, interpersonal interactions, and business behaviors are consistent with the Client's Code of Conduct.Main Responsibilities:
    • Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for nonconformances, potential nonconformances, CAPAs, deviations, and/or complaint investigations.
    • Is a subject matter expert on investigation and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
    • Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
    • Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
    • Produces trending metrics and reports to identify, prioritize and manage further actions, as may be required.
    • Provides leadership for the initiation of improvement activities associated with identified trends.
    • Is an active leader supporting a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
    • Ensures effective written and verbal communications.
    • Prioritizes workload in relation to the needs of the business.
    • Supports the attainment of Client's Point of Care goals and objectives.Prerequisite skills:
      • Knowledge of the Corrective and Preventative Action process in medical devices
      • Understanding of statistics
      • Experience with medical devices
      • Bachelor of Science in a life science or engineering discipline APPLY TODAY!

Keywords: Experis, Trenton , CAPA Process Analyst II, Professions , Princeton, New Jersey

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