Experience

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  Tissue Regenix Group

  • San Antonio, Texas, United States

  • Quality System Manager

    • Aug 2022 - Present
    • San Antonio, Texas, United States

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  Prytime Medical Devices, Inc.

  • Boerne, Texas, United States

  • Quality and Supply Chain Manager

    • Mar 2022 - Jul 2022
    • Boerne, Texas, United States

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  Tissue Regenix Group

  • Universal City, TX, United States

  • Senior Quality Systems Engineer

    • Nov 2020 - Mar 2022
    • Universal City, TX, United States

    • Manage CAPA System. Perform investigation, root cause analysis, and determination of corrective/preventive actions.• Manage Complaint Handling System from investigation to root cause determination.• Manage Non-Conformance Reporting System ensuring timely closure and effectiveness of all NCR’s.• Responsible for analyzing data and identifying trends. Assist in determining remediation strategies and CAPA escalation.• Responsible for ensuring that all departmental procedures promote accuracy, compliance, and lean business practices in accordance with global regulatory and company standards.• Manage electronic document control process, ensuring all QMS documents are properly created, approved, maintained, and ready for audit by regulatory and government agencies.• Assist in the development and re-design of QMS processes and procedures.

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  Brain Sentinel, Inc.

  • San Antonio, Texas Area

  • Sr. QA Specialist

    • Jan 2018 - Mar 2020
    • San Antonio, Texas Area

    • Participated as assigned QA representative on product development teams. Guide teams from Design Control process, ensuring compliance with ISO 13485 and 14971, FDA 21 CFR 820, European MDD, and internal QMS requirements. • Managed document control process, ensuring all QMS documents are properly created, approved, maintained, and ready for audit by regulatory and government agencies.• Responsible for ensuring that all departmental procedures promote accuracy, compliance, and lean business practices in accordance with global regulatory and company standards.• Responsible for creation of FDA 510k and CE Mark submissions with input from multiple departments including Quality, Regulatory, Marketing, Clinical, and Legal. • Managed employee training program, ensuring all employees are adequately trained and records are readily available.• Responsible for completion of incoming component inspection, first article inspection, final product release and associated report generation. • Managed CAPA System ensuring timely closure and effectiveness of all CAPAs. • Managed Complaint Handling System. Primary QA contact with suppliers and customers.• Managed Non-Conformance Reporting System ensuring timely closure and effectiveness of all NCR’s.• Responsible for facility FDA registration and listing activities as well as accurately maintaining the CE Technical File.• Manage audit war room and serve as SME regarding Document Control, CAPA, Complaints, Non-Conformance Reporting, Incoming/Product Inspection during multiple successful FDA and ISO audits.

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  Coastal Life Technologies

  • San Antonio, Texas Area

  • RA/QA Specialist

    • Jan 2016 - Jan 2018
    • San Antonio, Texas Area

    • Managed CAPA System ensuring timely closure and effectiveness of all CAPAs. Accountable for timely closure of CAPAs related to QA processes.• Managed Complaint Handling System. Primary QA contact with suppliers and customers.• Managed Internal Audit Program ensuring timely closure and effectiveness of all Internal Audits. Member of internal audit team.• Managed Non-Conformance / Discrepancy Reporting System. Accountable for timely closure of reports related to QA processes. • Supervised three (3) person Incoming QC Inspection team. Responsible for evaluating non-conformities and making disposition determinations.• Perform incoming inspection, in-process inspections, and final product release. Provide support to the manufacturing, purchasing, and warehouse departments.• Provide customer support for domestic and international product registrations, 510k and CE Mark submissions.• Responsible for facility FDA registration and listing activities and state licensing.

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  Vidacare

  • San Antonio, Texas Area

  • Documentation Control Specialist

    • Aug 2008 - Dec 2015
    • San Antonio, Texas Area

    •Managed the successful integration of a 3,000 piece hard copy document system into an electronic document management system (Agile).•Assist in the maintenance of standard operating procedures to ensure regulatory compliance with standards, guidelines and regulations (21CFR820 QSR and ISO 13485).•Responsible for maintaining and continuously improving the Document Control Systemin order to support business needs and ensuring to meet all regulations and established requirements, including record retention, format/numbering systems, and all aspects of change control.•Manage and maintain the inventory, routing, and tracking of all controlled documents including review, verification, and approval processes.•Manage the war room during multiple successful FDA and ISO audits. SME for all auditor questions regarding Document Control, Record Retention, and Equipment Calibration.•Provide required documentation for various international product registrations. Managed successful registrations worldwide, including tedious countries such as Japan, China, and Australia.•Complete QA review of lot/batch release records from contract manufacturers and provide approval for release, including the completion of First Article Inspections.•Performed various Quality Engineer functions, including running verification/validation tests for various products, including traveling to outside testing labs to perform on-site sample inspections.•Manage the calibration of all in-house testing equipment.

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  B. Braun Group

  • Carrollton, TX

  • Documentation Control Clerk I & II

    • Apr 2003 - Aug 2008
    • Carrollton, TX

    •Managed the successful integration of a 15,000 piece hard copy document system into an electronic document management system (Documentum). Directly train and supervise clerical staff of 6 employees.•Lead Documentation Clerk handling day-to-day management of department, reporting directly to the Director of Quality, during active 6 month search for new Documentation Control Manager. •Ensure Engineering Change Notices and the associated approved documents revisions are released into the system in accordance with procedures. •Manage/Update SAP 4.6 component and BOM data to reflect approved ECN changes as needed. •Ensure that quality records (NCRs, CAPAs, Internal Audits, etc) are filed / maintained as required by applicable procedures. •Manage the war room during multiple successful FDA and ISO audits. SME for all auditor questions regarding Document Control and Record Retention.•Use a variety of MS Office software systems to collect and report data required for recall and manufacturing deviations.