CAPA Process Analyst II

CAPA Process Analyst II

23 Dec 2021
California, Santaclara, 95052 Santaclara USA

CAPA Process Analyst II







Position Summary













The CAPA Process Analyst II:

- 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 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 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










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