• Assessed the current Quality Management System and implemented changes to ensure compliance with FDA Part 820 Quality System Regulation, ISO-13485, and ISO-14971.• Identified and established a Cloud-Based PLM (Product Lifecycle Management) system, along with a Quality Management System (QMS), and compliance with EU Medical Device Regulations (MDR).• Established and managed an Internal Auditing program, utilizing existing company human resources.• Developed a training program to educate staff and employees on the requirements of a Quality Management System in the Medical Device industry.

• Provided Quality Engineering support for manufacturing and development projects for a pressure catheter development project and a manufacturing company.• Managed the review and disposition of non-conformances.• Supported internal, customer, and supplier audits.• Performed additional support functions as assigned by the Quality Engineering Manager.

• Implemented the San Antonio facility's InCube Labs corporate Quality System and represented Quality Management in all activities there.• Established the Design Control process for new product development.• Led the development and implementation of Risk Management.• Performed and supported various quality processes including Receiving, Receiving Inspection, Risk Control and Management, Non-Conformance Management and disposition, Corrective and Preventive Action (CAPA), Calibration, In-process and Final Inspections, and Internal Audits.• Developed training protocols for site personnel.• Trained and managed Quality Engineers.

• Responsible for creating Validation Plans for manufacturing equipment with embedded software, including performing Computer Software Risk Analysis.• Developed Test Cases, authored Installation Qualification/Operational Qualification (IQ/OQ) and Performance Qualification (PQ) protocols, and compiled Summary Reports.

Assigned to Terumo Cardiovascular Systems, the role ensured that quality system issues identified by the FDA, third-party auditors, and internal auditors were effectively addressed. The assignment included managing CAPA remediation projects, implementing a revised management review process, automating the Incoming Inspection process, and providing support for validations, product and process development, manufacturing process control, complaints/recalls, internal audit, and quality control improvements.• Served as the Quality Engineering Manager and Quality System consultant.• Collaborated with Operations, Engineering, and Quality to ensure all process non-conformities were properly documented, tracked, and corrected.• Oversaw project management of remediation efforts for issues identified through NCR or CAPA investigations.• Conducted training for the new Quality Manager and Quality Engineering staff.

Tasked with developing and establishing the Quality Management System for a startup Drug Delivery medical device company.• Established Design Control, Materials Management and Supplier Control, Production Process Control, Quality Management, Environmental Control, and Complaint and Post Market Surveillance systems.• Performed duties as a member of a nine-person startup staff with responsibilities for developing and documenting the quality system, qualifying suppliers, training team members, and supporting design and process development through initiating design risk analysis (DFM).

• Established a risk management program compliant with ISO 14971, re-initiated quarterly quality management reviews, and completed FDA, ISO, and internal regulatory compliance audits.• Restructured the clinical complaint, post-market surveillance, and adverse event processes to provide a clear methodology for managing clinical and commercially released product corrective actions. Integrated these processes with the Risk Management and CAPA systems to streamline corrective action management.• Updated in-process inspection processes to enhance resource utilization, reduce backlog, address process non-conformances and yield issues, and improve cycle time.• Initiated the review and update of the supplier quality assessment process, defined and clarified part, material, and component acceptance criteria, and improved design definitions.• Assumed the role of Project Manager to ensure the timely delivery of engineering projects according to established timelines.

The primary goal was to address complaint, CAPA, quality systems, design control, and operations compliance issues highlighted in FDA warning letters, ensuring such compliance issues did not impede future PMA applications' approval.• Established and maintained quality systems that were compliant with FDA and ISO regulations and relevant industry and international standards.• Implemented and maintained a comprehensive quality system, representing the company during FDA and ISO audits. Interacted with FDA and ISO representatives as needed to address compliance observations. Managed the Internal Audit program.• Implemented a comprehensive Risk Management System in line with ISO 14971 requirements.• Ensured the quality of software products, tests, and quality system software complied with 21 CFR part 11 and applicable industry standards and regulations through software validation.• Designed and constructed an Environmental Test Facility for component and assembly qualification and life testing. Performed Failure Analysis on manufacturing and field-returned products.• Managed the Material Review Board, Corrective and Preventative Action Systems, and Risk Management database, reducing scrap and rework by over 50%.• Developed and organized a program management team with process owners from manufacturing, quality, engineering, materials, and clinical departments to prioritize resources and manage cross-functional projects.• Collaborated with clinical and post-market surveillance teams to implement product compliance corrective actions.• Developed and conducted new employee training programs and maintained training records.• Managed the production inspection function, establishing plans for reducing visual inspection and implementing the In-Process Audit concept.

• Accountable for establishing pro-active Quality Assurance, Product Test, and Reliability Engineering programs. • Developed a Quality Assurance and Customer Satisfaction Strategy improved the customer satisfaction, quality performance of products and services by correcting product performance issues and providing rapid customer feedback. • Implemented quality improvements that reduced warranty and non-conformance costs, assure compliance with regulatory standards, and reduced overall quality costs. • Realigned Quality Assurance System and addressed system deficiencies to assure compliance with ISO regulations/guidelines. • Established a corporate closed loop corrective and preventative action process with an escalation provision to advise executive management of high profile issues. • Organized and executed a complete re-writing of the Quality manual and operating procedures to reflect pro-active quality controls and initiatives.

• Established and maintained Quality Assurance System. • Designed and implemented Quality System for start-up Micro Electronics Hybrid Manufacturing facility in Scottsdale, AZ resulting in no observations during ISO compliance audit.• Managed internal and supplier auditing programs. • Implemented Supplier Certification program resulted in 97% acceptance rate at receiving inspection and above $300K annual savings.• Implemented inspection process improvements, statistical process control, and teamwork strategies that resulted in reduction of 40% in non-direct labor budget without change in product quality. • Organized process capability and continuous improvement initiatives to improve yield, productivity, and reduce quality cost.