I’m excited to announce that I’m working with a great team at Collins Aerospace with a title that sounds from a Star Wars movie…Associate Director, Enterprise Supplier Quality!

+Developing the Quality Systems strategy for Document Control, Training, and Electronic Quality Systems, in alignment with the Quality Assurance strategy to meet compliance goals.+Effectively organizing, leading, managing, and developing the Quality Systems team, including the Document Control and GMP Training functions, in a fast-paced environment.+Monitoring performance of the QMS (global training data and metrics, yearly periodic documentation review in Document Control, QMM data, and trends).+Analyzing and implementing process improvements to the QMS to ensure effectiveness, efficiency, and ongoing regulatory compliance. These improvements included the upgrade of MasterControl from a 2011 version to 2022, integrating the 2011 MasterControl documentation from the acquired company into Pacira’s current version, upgrading the Quality Events (such as NCMRs, CAPAs, Quality Events, Issues, OOS, Deviations, etc.) forms in the latest revision of MasterControl.+Maintaining controlled documents and records of compliance activities.+Developing, implementing, managing, and renewing QMS metrics, project dashboards, and department plans at an appropriate frequency and presenting this information at QMM (Quarterly Management Meetings) to the executive leadership. +Creating liaisons across the business to build relationships, remove silos, communicate, train, and support internal and external customers with QMS and GMP compliance, processes, policies, and procedures.+Writing, reviewing, and revising as necessary QMS policies and procedures.+Supporting regulatory inspections and partner audits.+Working with all Quality Systems vendors on contract development, budget allowance, resource balance, and technical support descriptions.+Managing three Quality Systems groups in a fast-paced environment while delegating effectively, leading staff, providing guidance and coaching, developing employees, balancing workload, and resources, and sharing a joint mission and vision.

+ Chair of Material Review Board at Illumina's Headquarters+ Quality Leader of two Production areas (Flowcell Manufacturing and Flowcell Fabrication)+ Coach, Mentor, and Trainer of Quality Systems and Quality Tools

+ Creates the concept, methodology, and requirements of the MFG GMP 2015 Program and electronic system.+ Leads cross-functional Core and Compliance Team in the implementation and execution of MFG GMP 2015 Program with the goal of effectively carrying out Illumina’s Clinical Transformation. + Develops company-wide surveys to bring awareness, teach, and emphasize the sections of the 21 CFR 820 Regulation that are applicable to the Diagnostics Manufacturing areas.+ Presents company-wide training on MFG GMP 2015 Program to Vice-Presidents, Directors, Managers, Supervisors, and Operators in La Jolla (Headquarter), Singapore, and Hayward Illumina facilities.+ Provides Technical/Customer Support to all participants of the MFG GMP 2015 Program on a daily basis addressing questions, concerns, and feedback about the program and electronic system.+ Analyzes and generates reports for upper management that shows compliance gaps and areas for Continuous Improvements as outcome of the program. + Performs weekly assessments of Diagnostic Manufacturing Areas to capture any GMP deficiencies. The assessments also serves as a training tool to Supervisors/Managers on how to conduct self-assessments of their areas.

+Drives Quality Systems developments and improvements throughout the organization, utilizing and analyzing data accumulated through the various processes in the organization.+Reviews and approves as Quality Representative all company change orders submitted in the company’s electronic Document Control System. +Manages the following Quality Systems: Corrective and Preventive Action and Complaint System, Material Review Board Program, Continuous Improvement, Risk Analysis, Batch Record Release, Quality Control Inspection (Incoming, In-Process and Final), and Management Review.+Supervises staff in a variety of Quality Systems and creates goals and monitors for departmental improvement.+Reviews regulatory requirements and implement policies within the Quality Management System to comply with these requirements.+Performs audits and acts as Quality Representative for customer and regulatory/ISO audits.+Trains staff bimonthly in Quality tools and Quality Systems such as Material Review Board, Auditing, CAPAs, Complaints, and QC Inspection.

+ Quality Systems TrainerPerformed company-wide training in the following QA areas: Validation (IQ, OQ, & PQ), GMP Documentation Practices, Deviations, Variances, Rework, Line Clearances, ANSI/ASQ Z1.4 Sampling Plan for Inspection by Attributes, CAPA (Corrective and Preventive Action) System, Root Cause Analysis, and Customer Complaint System.+ Quality Systems AnalystWrites and analyzes, for upper management, monthly, quarterly and yearly data trends of all Quality Systems in the following areas: Audits, Validations, Document Control, Non-conformances, Incoming Inspection, Final Product Inspection, Calibration and Environmental Monitoring, Customer Complaints, Corrective and Preventive Actions, QA Batch Record Releases, Deviations, Variances, Reworks, and Out of Specification Documentation. + Lead Auditor of QSR and ISO requirementsWrote plans, performed audits, wrote reports, and held closing meetings for several internal audits which included the following content: Information Systems, Facilities and Maintenance, Inventory, Purchasing, Clinical Lab, Quality Control, and many Production areas. In addition, performed audits of key suppliers. + Lead Investigator of Top Customers’ Complaints and CAPAsPerformed investigations, provides reports, and interacts with top customers utilizing Quality Engineering tools such as FMEAs, Fault Tree Analysis, and Fishbone Diagrams.+ Validation CoordinatorManaged the Validation Database System (Microsoft Excel). Reviewed, developed, and executed several equipment and process validation protocols and reports.+ Miscellaneous Quality Activitieso Develops and implements Manufacturing Processes and Quality Systems procedures which included flowcharts and forms.o Dispositions and approves Non-Conforming Material. QA Representative in the Material Review Board (MRB).o Reviews and writes QC Inspector’s Sampling Plans.o Writes Quality related topics in the company's monthly Quality Newsletter.

+Chairperson of Validation Review Committee (VRC)Administrator of the Validation Database System. Ensured compliance of the validation system to quality and regulatory standards. Reviewed all company validation protocols and reports for technical content, completeness and compliance. Provided sampling plans and statistical analysis in the validation protocols and reports for equipments and manufacturing processes.+Co-Chair of the Material Review Board (MRB)Monitored and updated the Non Conforming Materials/ Corrective Action System database(Microsoft Access). Performed technical root cause failure investigation and analysis, material disposition and corrective action implementation of production issues on a daily basis.+Quality Representative in Product Development/R&D projectsDeveloped material and process specifications. Implemented supplier, material and quality inspection control plans and quality test plans. Participated in development of process FMEAs.+Quality Engineering ActivitiesProvided daily support to receiving inspection, in-process inspection, and finished goods inspections. Presented monthly scrap data to upper management to highlight top production issues and performed continuous improvement of these issues. Developed attribute boards and procedures that showed examples of acceptable and rejectable product for manufacturing personnel at Quidel and for a supplier. Performed statistical analysis that included normality test, control charts, process capabilities, t-test, Gage R and R, and others from production data.+Auditor of QSR and ISO requirementsDeveloped plans, reports and presented to upper management audits of the following areas: Production Data Analysis, Warehouse/Shipping, Inventory Control, Human Resources and training records for Information Systems and Sales.

•Coordinated Material Review Board (MRB) weekly meetings which resulted in the disposition and completion of paperwork related to the release of non-conforming product. •Coordinated the “Corrective and Preventive Action” program, which managed internal, supplier, and customer issues.•Developed documentation which regulated visual inspection and dimensional measurements for Quality Control personnel.•Verified specification documents and drawings for properly identifying parts based on customer requirements. •Interfaced with inter-departmental personnel, suppliers, and customers regarding Quality issues. •Audited internal compliance with the ISO 9000/AS9000 standards. Coordinated audits and action items from customer and industry standards verification.•Developed and enhanced manufacturing and quality procedures.•Supported the outsourcing of QA functions and manufacturing operations to Ensenada, Mexico.

+SPC Team Leader: Implemented Statistical Process Control in Operations and Quality Assurance. Developed a SPC Control handbook. Developed and presented SPC training to VPs, Directors, Managers, and Engineers. +Auditor of QSR and ISO Requirements: Performed process controls, purchasing controls, and management review audits. +QA Project Leader of SW development: Verified SW development documents such as, development plans, requirement definitions, design documents, alpha test protocols, validation test protocols, design review checklists, etc. Participated in the complaint tracking system and medical device-accessory software projects. +Validation Leader: Developed company validation system procedures and modified process and equipment procedures. Developed qualification protocols, deviation reports, and summary reports for process and equipment validation. Developed and presented validation system training to Directors, Managers, and Engineers.

+Validation Project Leader: Validation of production line equipment for medical device processes. Developed Validation Master Plans, validation protocols and reports(IQ, OQ & PQ) for equipment and processes. Reviewed process software validation documentation to ensure FDA compliance. +Validation System Coordinator :Participated in the development and modification of company’s validation procedures. Developed new and modified existing templates for validation documentation. Developed and produced a company-wide “Validation Newsletter” to educate employees on validation system changes and provide validation requirements clarification.+Validation Trainer: Developed and presented training to Directors, Managers, and Engineers in the areas of RD & E, Operations, and Quality Assurance on company-wide validation systems. Developed and presented interactive training on how to write validation protocols to engineers involved in validation projects.