Jackeline Diaz-Ayala

About Jackeline Diaz-Ayala

I graduated from University of Puerto Rico at Mayaguez (RUM) with a B.S. in Chemical…

Experience

1. Quality Manager

   Abbott

   Apr 2021 — Present

   Manage an organization of 45 employees in the areas of Quality Engineering, Quality Assurance, Quality Inspectors and Quality Technicians that provide quality operations support to MitraClip manufacturing- Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization- Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed. Manage development and performance of direct reports- Actively use risk management and data to make decisions on product quality and ensure patient safety- Serve as an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements- Mentor and coach engineers to DMAIC (Define, Measure, Analyze, Improve and Control) CAPA process. CAPA Instructor and Site CAPA SME. Oversee the Nonconformance and Real-time data management portions of the Quality System. Special Project Assignment: New Greenfield Site and Product Transfer Project Apr. 2021 – Dec. 2022 - Quality Management representative during new Abbott greenfield in Westfield, IN. Provided quality oversight of construction activities- Led and drove Process Validation activities including validation strategy, validation master plan, OQ and PQ for the product transfer project from Menlo Park, CA to Westfield, IN- Successfully completed Internal Audits, Abbott Regulatory Audits, FDA Inspection and BSI Audit for site transfer and represented the site as Generalist during audit execution- Built new Quality Operations organization as part of site startup.

Education

• University of Puerto Rico-Mayaguez

  B.S. Chemical Engineering

• University of Puerto Rico-Mayaguez

  Bachelor's degree, Chemical Engineering

  2007 — 2013

Skills

• Continuous Improvement
• Fda
• Engineering
• Powerpoint
• Food Science
• Data Analysis
• Cross-Cultural Communication Skills
• Design of Experiments
• Microsoft Office
• Cross Functional Team Building
• Bilingual Communications
• Quality System
• Maximo
• Gmp
• Root Cause Analysis
• Six Sigma
• Adobe Design Programs
• Research
• Leadership
• Process Engineering
• Chemistry
• Cross-Functional Team Leadership
• Microsoft Excel
• Quality Assurance
• Process Improvement
• Troubleshooting
• Medical Devices
• Green Belt
• Teamwork
• Validation
• Manufacturing
• Equipment Installation
• Pharmaceutical Industry
• Spss
• Cognos Reportnet
• Testing
• Supplier Quality
• Higher Education
• Chemical Engineering
• Teaching