ASQ certified quality engineer / manager with proven success in product development, manufacturing, and product support. Establish and maintain processes and procedures to ensure that product quality and process performance conform to customer, business, and applicable regulatory requirements.

Supplier Quality Engineer @ Provide quality engineering support for the supplier base incoming rejects, on line rejects, and customer complaints. Utilize the organization operating systems Lean and Six Sigma enablers to drive continual improvement. • Ensure the supplier chain quality improvement through performance monitoring, feedback assessment, and effectiveness review of the process controls implementation. • Participate in the Corrective Action Board and disposition Nonconforming Material. • Initiate, review, and approve engineering drawing changes as a part of the ECR process. • Support site Built-In-Quality initiative. From July 2012 to Present (3 years 6 months) Quality Manager @ Managed the quality assurance department and quality systems to ensure product quality, document control, and compliance to customer and regulatory requirements. Interfaced with customers and suppliers in matters related to quality. Supervised ten people. • Quality systems planning and management to ensure compliance to ISO 9001:2008. • Responsible for management reviews, 3rd party audits, and supplier management processes. • Administered the CAPA system, quality systems audits, and customer complaint resolution. • Responsible for the MRB process, SPC, and management of IQ/OQ/PQ process validations. From January 2011 to January 2012 (1 year 1 month) Quality Associate II / Quality Manager @ Partnered with regulatory and compliance departments to ensure product quality, performance and safety, and conformance to regulations. Contributed to meeting regulatory, technical, business, financial goals, and minimized the time to market through participation in the design transfer process. • Participated in the Change Control Board (CCB), design reviews, design verifications and validations, and FMEA’s activities in a cross-functional team environment. • Performed supplier quality assessments, and provided feedback on risk management activities to ensure compliance to ISO 14971. • Contributed to meeting regulatory and technical goals, and minimized time to market through leading the design transfer activities. From June 2007 to February 2010 (2 years 9 months) Quality Systems Manager / Quality Specialist @ Implemented and maintained a suitable and effective quality management system using FDA CFR 21 Sub-Part 820, ISO 13485, and other applicable regulations. Accomplished organizational goals through effective planning, organizing, and leading of organizational resources. • Established quality procedures and process flowcharts, leveraging design principles to meet strategic goals of high reliability product design and lower warranty costs. • Sustained Quality organization by maintaining the design history file, device master record file, and processed engineering change orders. • Collaborated with other departments on quality processes. From March 2004 to June 2007 (3 years 4 months) Document Control / Process Control @ Provided document control coordination, maintained CAPA database, and customer complaint files while reporting to the VP of QA & Regulatory. Managed production schedule through an MRP system, equipment calibration schedule, and performed batch reviews. • Maintained the integrity of the quality system during change control by keeping the latest revisions in the design history file and device master record files. • Participated in the Materials Review Board (MRB), coordinated CAPA activities, and ensured timely inspection of raw materials, in-process, and final inspection of devices. • Enhanced supply chain operations and ensured compliance to ISO 9001:2000 by facilitating purchasing, receiving inspection, and supplier quality management activities. From January 2000 to March 2004 (4 years 3 months) QC Lead Inspector / Manager Assistant @ Managed team responsible for the connectors contacts product line and quality control. Modified solutions to enhance business processes operation, information flow, and eliminated redundancy. • Eliminated calibration process variation and inefficiencies, which significantly improved the quality level by eliminating 20% defects. • Improved operational efficiencies through mentoring and training of employees. • Achieved the Preferred Supplier Status certification by optimizing the calibration workflow. From December 1988 to January 2000 (11 years 2 months)

Master of Science in Quality Assurance, 3.9 @ Cal State University Dominguez Hills From 2009 to 2011 Bachelors of Arts in Business Administration, General Management @ Cal State University Fullerton From 2002 to 2005 ASQ Courses Lucia MSQA is skilled in: Quality System, ISO 13485, Blueprint Reading, Inspection, Internal Audit, Supplier Quality Management, Quality Assurance, Supplier Quality, ISO, Six Sigma, Continuous Improvement, Lean Manufacturing, SPC, Iso 9000, Quality Control