SUMMARY

• CQA, CQE Certified Bilingual Electronics and Quality Assurance Engineer with over 20 years’ experience in Quality, Process and Manufacturing Engineering for manufacturers of aerospace, medical devices, and industrial electronics.
• QMS implementation & management (AS - 9100/ISO-13485:2016, ISO-9001:2015), six sigma green belt, lean manufacturing, process and continuous improvement, cost of poor quality and reliability, SPC, KPIs enhancement, cost and scrap reduction, kaizen, 6S, 8D.
• R&D/Product/Process verification and validation protocols, DQ/IQ/OQ/PQ, DOE, D/PFMEA, CAB, CCB, CRB, MRB, CAPA, internal and external certify lead auditor, supplier evaluation, selection, qualification, approval and certification.
• SCRAM, RMA, customer complaint investigation, calibration, metrology.
• Experience with AS-9100, ISO-9001, ISO-13485, FDA 21 CFR, IVD/MDD standards and related quality processes.
• Knowledge in planning and performing validation activities, IQ, OQ, PQ.
• Systematic approach to problem solving and continuous improvements.
• Self-motivated with the ability to work independently and in a team environment.
• Possess excellent communication, organizational and troubleshooting skills.
• Work safely always and maintain the confidentiality of all customer and company information.
• Understanding leading cross functional improvement projects.
• Strong in SPC and statistical data analysis.
• Certified lead auditor.

PROFESSIONAL EXPERIENCE

Confidential, San Diego, CA

Sr. QA Specialist

Responsibilities:

• Supported QMS processes in compliance with ISO 13485, 21CFR820, applicable regulatory requirements and Quality Policy.
• Managed calibration program, maintained calibration database, scheduled calibration and repair services.
• Performed in-house calibration in accordance to documented procedures.
• Coordinated with supplier’s calibration of company’s measuring equipment. Documented supplier’s calibration procedures.
• Managed Out of Tolerance database and generated OoO reports and follow up with CAPA as required.
• Supported the Cleanroom environmental monitoring process.
• Performed supplier qualification, supplier monitoring and supplier corrective actions (SCAR) processes, follow up and effectiveness verification.
• Coordinated suppliers’ audits and maintained QA records.
• Assisted in Complaints handling, MRB and CAPAs.
• Assisted in audits and published audit reports (Internal and External).
• Assisted QA management with special projects, process trending, and monthly/quarterly reporting.

Confidential, San Diego, CA

Supplier Quality Assurance Engineer

Responsibilities:

• Collaborated with Supply Chain Mgmt. to develop and maintain an effective Supplier selection and approval process, and recommended course of action with poor performance suppliers.
• Participated with Engineering and Supply Chain in the identification of strategic suppliers and their associated risk level.
• Performed onsite source inspection to support GD-OTS flow down requirements compliance.
• Coordinated process change request with suppliers, assisted with submittals. Monitored the performance of the CAPA system.
• Developed proactive continuous improvement activities based on the GD-OTS performance trend requirements.
• Engaged in the MRB, CCB, and CAB processes to drive actions with poor performance suppliers.
• Ensured metrics for suppliers were developed, maintained, and reviewed to promote continued and sustained success.
• Developed and maintained a supplier-subtler audit/surveillance program, which included coordinating GD-OTS and customer product processes.
• Performed FAI review and approval to support suppliers to comply to GD-OTS part approval flow down requirements.
• Reviewed/audited records, testing plans, risk analysis.
• Performed root cause analysis of supplied product quality issues. Applied appropriate tools (e.g. statistics, fault tree analysis, etc.). Worked with Suppliers to develop effective corrective actions.
• Supported the NC and CAPA processes by performing investigations and root cause analysis, determining action plans and driving the actions to closure with suppliers.

Confidential, San Diego, CA

Quality Assurance Engineer

Responsibilities:

• Participated on design transfer, design control and improvement project teams.
• Reviewed/audited records, testing plans, risk analysis.
• Performed root cause analysis of product quality issues. Applied appropriate tools (e.g. statistics, fault tree analysis, etc.). Worked with peers to develop corrective actions.
• Performed failure mode analysis on new or existing products. Worked with peers to developed mitigations for failure modes and verified the effectiveness of these mitigations.
• For both new products/processes and changes to existing products/processes developed verification and validation plans that assess if requirements were met. Oversee the execution of verification and validation plans. Wrote reports that summarize the verification and validation results.
• Supported the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
• Supported the NC and CAPA processes by performing investigations and root cause analysis, determining action plans and driving the actions to closure.
• Demonstrated commitment to the development, implementation and effectiveness of Confidential /Abbott QMS per ISO, FDA, and other regulatory agencies. Carried out duties in compliance with established business policies.

Confidential, San Diego, CA

Sr. QA Engineer

Responsibilities:

• Established and maintained quality system documentation to ISO standards.
• Defined complex Quality Engineering processes and regulatory requirements.
• Applied systematic and analytical approach to problem solving and continuous improvement.
• Reviewed internal/external business challenges and made recommendations for improvements to products, processes or services.

Confidential, San Diego, CA

Sr. Quality Assurance Engineer

Responsibilities:

• Provided technical and regulatory expertise for a range of quality assurance testing and inspection activities associated with product development and manufacturing processes.
• Performed internal audits of the operation process using inspection results and statistical techniques to provide timely, accurate process and product analysis.
• Performed root cause analysis initiatives for process related concerns.
• Analyzed audit results and determines proper corrective and preventive action.
• Defined and conducted both systematic/methodical and random/arbitrary tests to ensure proper performance of products.
• Reviewed and created inspection forms, records, techniques and procedures for accuracy and relevance and provide changes when necessary.
• Exercised consistent independent judgment and discretion in matters of significance.
• Defined complex Quality Engineering processes and regulatory requirements.
• Applied systematic and analytical approach to problem solving and continuous improvement.
• Reviewed internal/external business challenges and made recommendations for improvements to products, processes or services.
• Demonstrated analytical skills to proactively identify and solve problems.

Confidential

Sr. Quality Assurance Engineer

Responsibilities:

• Manage Company QMS (ISO-9001:2015/ISO-13485:2016/AS-9100:2016/ FDA 21CFR Part 820 and 11) and certification requirements.
• Ensure process compliance through the development of comprehensive procedures, work instructions, and other process related documentation.
• Assure that all Quality aspects and customer requirements and expectations are being satisfied in all facets of manufacturing process steps.
• Compile data to monitor effectiveness of Internal Audit Program and Corrective and Preventive Actions (CAPA) Program.
• Leaded training (SPC, Calibration, ISO Quality System, Auditing, CAPA, MRB, etc.) of personnel.
• Identify and execute lean solutions for improvements in productivity, costs, quality and safety.
• Manage documentation control for auditing procedures, processes and corrective actions.
• Leaded training for Quality Engineers, QA technicians, and production personnel.
• Leaded lean projects and implemented continuous quality improvement activities.
• Collaborate in Supplier Qualifications and ongoing quality control requirements.
• Ensure timely resolution of supplier failure, corrective actions and preventative actions.
• Manage supplier’s performance, risk mgmt. activities and conduct audits.
• Manage the preparation of QA reports and metrics for Mgmt. Review.
• Lead in External Audits by customers or regulatory bodies.

Confidential

Program Quality Assurance Engineer

Responsibilities:

• Supported compliance to QMS, EEP’s and AS9100.
• Performed audit preparation activities (pre-work, checklists, meetings etc.) within VS.
• Communicated internal and external quality audits to Leadership team.
• Generated trends in repeat errors, FPY, delivered quality, etc. and determined corrective action activities.
• Assisted VS Leadership with the appropriate and timely resolution of corrective actions.
• Lead/Co-Lead CV Operations QCAB Meetings. Reported CAB metrics for weekly Health Measures Meeting.
• Scheduled and conducted Quality Clinic DIVEs.
• Managed CAPA and Quality Metrics for PDPR activities.
• Managed CV Ops AMQAS Plan and Surveillance.
• Supported ACE and Standard Factory Initiatives.
• Developed SPI’s for key tasks and activities.
• Controlled quality, productivity and process flow to meet MRP requirements while ensuring a high level of customer satisfaction.

Confidential

Supplier Quality Assurance Engineer

Responsibilities:

• Implemented Zero Defect Plans (ZDP) at critical suppliers as part of the larger UTC initiatives. ZDPs include the use of RRCA/UPPAP/ProCert.
• Reported on supplier’s plan and progress made to program team on a regular basis. Traveled to aid suppliers in RRCA and closing actions.
• Identified areas of improvement within the organization and hold ACE events to solve the high-risk supplier problems.
• Performed quality problem resolution, processing and closure of supplier quality notifications (escapes, disclosures), on-time closure and follow-up of all associated corrective actions.
• Followed up on assigned suppliers in systemic root cause corrective action analysis and track supplier actions.
• Supported quality system, product, and technical process audits.
• Flowed down of supplier quality systems including auditing requirements.
• Coordinated supplier audit schedules, tracked and monitor audit results.
• Monitored supplier & audit to plan, annual surveys and supplier score card.

Confidential

Sr. Quality Assurance Engineer

Responsibilities:

• Established and maintained quality system documentation to ISO standards.
• Performed reviews of design documentation for compliance, including supplier quality manuals and company quality records.
• Managed CAPA corrective/preventive action system process.
• Managed MRB activities and developed Quality Control Plans for processes, product and components.
• Managed calibration system, receiving, in-process and final inspection activities.

Confidential, Anaheim, CA

Quality Assurance Engineer

Responsibilities:

• Planned and conducted the analysis, inspection, test, validations, and/or integration to assure the quality of assigned products or components.
• Performed reviews of design documentation for compliance, including supplier quality manuals and company quality records.
• Applied Statistical Process Control (SPC) methods for analyzing data to evaluate the current process and process changes.
• Reviewed all purchased products or components and provided input to accept the product and future purchases from the suppliers.
• Documented data obtained during all Quality Assurance activities, consistent with company policies and procedures.
• Developed new approaches to solve problems, and communicated significant issues or developments identified during Quality assurance activities and provided recommended process improvements to management.
• Prepared reports and presented technical data to team members and management.
• Developed and implemented Standard Operating Procedures, Work Instructions, Forms and Records to support the Quality Management System.
• Managed MRB activities and developed Quality Control Plans for processes, product and components.
• Managed the Internal Audit Program to comply with the ISO-9001, AS-9100 and ITAR.
• Performed internal and external Quality Management System audits as Lead Auditor.
• Performed Process Capability Studies and implemented improvements as needed.

Confidential

Sr. Quality Assurance Engineer

Responsibilities:

• Developed and implemented methods and processes for design, inspection, testing, quality-planning, fabrication and production of raw materials and finished product to reduce process time and cost and evaluated the precision and accuracy of products and/or production equipment.
• Performed internal and external quality audits, selection and evaluation of new and existing suppliers, evaluated their facilities and quality systems for compliance, and followed up all corrective actions to prevent recurrences (ISO re-certification and Intel SSQA Award for three years in a row).
• Developed and managed the electronic Non-Conforming Material Report (NCMR) and the Supplier Corrective Action Request (SCAR) databases (issuance, approval, disposition, follow-up, and closure).
• Developed and evaluated supplier scorecards and performed Cost of Poor Quality (CoPQ) analysis (reduced supplier caused CoPQ by 15% for two years in a row).
• Evaluated suppliers under the Supply Chain Risk Assessment Management (SCRAM) program, developing and implementing risk mitigation plans for those categorized as high risk.
• Identified the need and coordinated the IPC-A-610D training event for the company.

Confidential, Santa Fe Springs, CA

Sr. Quality Assurance Engineer

Responsibilities:

• Performed quality-planning activities for new or revised materials or products and ensured customer quality requirements.
• Supported receiving, in process, and final inspection activities to ensure compliance, evaluated and adjusted manufacturing processes or product deficiencies to reduce time, rework and scrap and improve product quality and reliability.
• Developed, implemented and maintained supplier quality assurance system, evaluation, selection and monitoring of suppliers and their materials, certification activities, the same as processes and compliance to reduce cost, rework and customer complaints.
• Developed CAPA system to monitored and controlled all supplier quality issues and quality cost.
• Performed internal and supplier quality audits.
• Managed the metrology and receiving inspection areas, engineering inspection criteria, sampling plans, training and certification of auditors and technicians.

Confidential, Irvine, CA

Sr. Quality Engineer

Responsibilities:

• Developed and maintained quality system and performed failure analysis investigations.
• Implemented and monitored quality and reliability activities to ensure compliance to contract specifications, supplier quality, certification activities, acceptance sampling, problem solving.
• Managed CAPA corrective/preventive action process and audit system, RMA analysis, engineering review activities, metrics generation, calibration system, supplier quality certification program and cost of quality.
• Ensured compliance with FDA Regulations and ISO standards.
• Conducted IQ/OQ/PQ protocols, calibration/maintenance and validation of specialized test equipment.
• Performed safety and reliability testing to support new product releases.

Confidential, San Clemente, CA

Sr. Quality Engineer

Responsibilities:

• Performed design review and validation of R&D product.
• Developed and maintained quality system and performance failure analysis.
• Ensured raw material performance standards, cost of quality and reliability.
• MRB, CRB representative, responsible for CAPA corrective/preventive action process and audit system, RMA analysis.
• Conducted IQ/OQ/PQ protocols, calibration/maintenance and validation of specialized test equipment.
• Evaluated the qualification, assessments, audits, surveys for supplier/commodity technology, process and systems capabilities in the supplier selection process, inspection/test methods, and failure analysis investigations.
• Ensured compliance with FDA Regulations and ISO standards.
• Performed safety and reliability testing to support new product releases.

Confidential, Santa Ana, CA

Sr. Quality Engineer

Responsibilities:

• Reviewed customer contracts, performed planning activities for new and revised product, test procedure/process review, product configuration and validation process, engineering change control, cost of quality and reliability.
• Conducted design review, evaluation and disposition of nonconforming materials (MRB), material and inventory control, corrective/preventive action system process, engineering review activities, metrics generation, SPC, calibration system, supplier quality certification program, AS-9100 certification program, AQP liaison support.
• Conducted protocols/reports, calibration/maintenance and validation of specialized test equipment.
• Evaluated the qualification, assessments, audits, surveys for supplier/commodity technology, process and systems capabilities in the supplier selection process, inspection/test methods, and failure analysis investigations.
• Reviewed and ensured compliance with FAA Regulations and the international quality system standards in all activities.

Confidential, Huntington Beach, CA

Quality Engineer

Responsibilities:

• Established and maintained quality system documentation to ISO standards.
• Managed CAPA corrective/preventive action system process.
• Maintained calibration system, receiving, in-process and final inspection activities.
• Performed mechanical and electronic testing. Troubleshoot units for performance failures. Completed evaluation of specifications and final test, tolerances and workmanship standards.

Confidential, Lake Forest, CA

Quality Engineer

Responsibilities:

• Developed procedures, statistical and failure analysis, inspection and validation activities for IV subassemblies and disposables from suppliers, subcontractors, and manufacturing, final product buy-off.
• Performed final product approval and testing. Performed incoming inspection, process control and functional validation of medical products.
• Evaluated new products and laboratory work, performed SPC inspection and process control, GMP’s and ISO standards.
• Performed safety and reliability testing to support new product releases.

Confidential, Irvine, CA

Quality Engineer

Responsibilities:

• Performed final functional test and troubleshoot wireless communication systems, FMEA generation.
• Completed evaluation of specifications and final test, tolerances, and workmanship standards.
• Maintained the quality system documentation to ISO standards.
• Performed environmental and reliability product testing.

Confidential, Irvine, CA

Production Supervisor

Responsibilities:

• Performed setups and maintenance on production equipment.
• Performed first articles (FA), MRB and verification of quality at final assembly and test.
• Implemented SPC and process control programs.
• Scheduled crew and production assignments.
• Maintained attendance log and production reports.