Pamela Madrigal

Lead Supplier investigations and assure quality non conformance are investigated and robust corrective actions are accomplished.

• Analyzed issues with supplier contributions to detect defect trends, reporting findings to appropriate personnel.
• Designed inspection plans and methods for execution by personnel at remote locations, verifying accurate implementation and data collection.
• Resolved supplier quality control issues through collaboration with third-party leadership.
• Aided suppliers in raw material selection strategies to encourage superior supply chain outcomes.
• Maintained amiable relationships with suppliers through difficult quality control issues, supporting healthy business interactions.
• Conducted supplier audits to detect pre-production weaknesses in supply chain and human resource assets.
• Approve and guide supplier 8D investigations
• Support at investigations and lead for relentless root cause analysis robust corrective action.
• Assure supplier has Robust ZDP (Zero Defect Project) to avoid re-occurring escapes
• Assure manufacturing process are being followed for high quality by performing MPR (Manufacturing Process Review)
• Participate in NAR (Non Advocate Review) events as guidance for other colleagues support
• Focal for PR plant site
• Analyze data and determine focus suppliers for improvements
• Prepare metrics and executive summary of supplier activities
• Participate at Quality Council meetings for Quality Issue Management (QIM) system improvements

Lead QE for customer escapes between PR and Phoenix site

• Distribute and administrate all escapes and corrective actions.
• Lead 8D investigation robust systemic mistake proof solutions mitigating re-occurrence. Reinforcing read across at all time.
• Present investigations and results in executive summary presentation for SR CABs.
• Improve communications and customer relationship
• Travel as required to organize reworks at PHX site
• Support all customer claim for Quality Improvements
• Improve procedures, monitor and audit CA’s.

• Contributed to root cause analysis to determine core reason for failures and errors.
• Coordinated with quality control staff to complete inspections.
• Performed quality inspections and drafted reports to detail non-conforming material issues.
• Supported quality team members during corrective action updates.
• Built strong rapport with team members, management and clients to facilitate efficiency and productivity.
• Demonstrated product and quality expertise in product inspections.
• Participated in multi-disciplinary defect reviews to discern and address root causes.
• Produced reports on diagnostic outcomes, non-compliance issues and other negative factors discovered during production.

o Special projects: Lead My Quality lives on and handling campaigns inside the site at PRO.

o Lead for the Corrective Action Board (CAB) - 2011-2013

• Support at investigations and lead for relentless root cause analysis robust corrective action.
• Enforce continues improvements in all manufacturing areas.
• Monitor all proposed preventive and corrective actions to be implemented.
• Evaluate all corrective actions presented by Engineers are robust and eliminate re-occurrence.

• Investigate non-conforming external and internal
• Work on RCCA using methodology Quality tools such as Fish Bone, 3X5 Why, Elephant charts etc.
• Work with CFMEA and maintain PFMEA up to date.
• Worked on several validations
• Continuously comply with all regulatory related requirements.
• Conduct Internal and External audits.
• Design and/or implement methods and procedures for inspecting, testing, and evaluating precision and reliability of products and/or production and/or test equipment
• Analyze derivable of each project to be submitted at change control sponsor
• Lead or support change control implementations
• Present changes and improvements under change control approvals (ECR)
• Updating or disposition of nonconforming materials
• Cost impact
• Monitor effectiveness
• Document and investigate non-conforming products condition and/or deviations.
• Create documentation for inspections/procedures
• Interact with suppliers either telephonically or in person to develop and standardize inspection methods and or techniques to ensure components compliance with specifications
• Audit suppliers
• Perform and/or approve validation, support for product, processes, packaging, software, and sterilization
• Analyze reports and/or returned products and recommend corrective action
• Conduct failure analysis of products and processes: Problem solving efforts, Reliability design improvements, Product failure trending.
• Perform, develop and document corrective and preventive action (CAPA)
• Lead and Implement new concept of Process Picture Mapping (PPM)

• Collected, arranged and input information into database system.
• Gathered, organized and input information into digital database.
• Generated reports detailing findings and recommendations.
• Create statistical analysis for Manufacturing and Packaging Parameters
• Report all Deviations
• Change Controls and Complaints
• Support to Technical Services on process investigations and deviations resolution change Controls and complaints..