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Veterans at Abbott

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Abbott Corrective Action Preventative Action Analyst II in Alameda, California

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 103,000 colleagues serve people in more than 160 countries.

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 non-conformitie's, 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 multi-functional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct.

Responsibilities:

Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for non-conformance'''s, potential non-conformance's, 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 non-conformance.

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 ADC goals and objectives.

Qualifications:

Bachelor degree or equivalent experience (i.e. minimum of 4 year’s work experience in the medical device/pharma/biotech industry).

  1. Minimum of four (4) years of experience working in a regulated environment or experience performing investigations.

  2. Good working knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 preferred.

  3. Good working knowledge of investigational and Root Cause Analysis Techniques.

  4. Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.

  5. Good 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.

  6. Must be able to work independently.

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 corpjat@abbott.com

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