CAPA Process Analyst II

Title: CAPA Process Analyst II

Location: Milpitas, California

Duration: 6+ Months

Responsibilities:

• 4+ Years 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 Abbott Code of Conduct.
• Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for non-conformances, potential non-conformances, CAPAs, deviations, and/or complaint investigations.
• 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 Abbott Hematology goals and objectives.

Prerequisite skills:

• Knowledge of the Corrective and Preventative Action process in medical devices, understanding of statistics Experience with medical devices which have reagents, complex electro-mechanical and optical components.
• Bachelor of Science in a life science or engineering discipline

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.