Manufacturing Quality Technician - Genentech - South San Francisco, CA
(2021-01)
- Performed investigations of significant event deviations along with the corresponding root cause analysis (RCA), impact assessment and trend evaluations.
- Supported assigned Corrective and Preventive Actions (CAPA).
- Primary point of contact for all Quality related issues: assessments product failures, returns, technical issues, process issues, corrective actions.
- Perform particle inspections on different production departments and in the packaging department prior to shipping product to the customer.
- Develop and review trend analysis reports related to the scope of work.
- Supported Engineering in preparing internal and external reports /KPI's.
- Assisted Engineering in generating / updating ISO documents and SOP's.
- Performed routine audits and periodic spot inspections on GMP cleaning operations to observe, evaluate and provide Genentech Quality Manager and Account Manager copies of findings.
- Collaborated with engineering on the site's self-assessment program along with the corrective actions as a result of findings.
- Collaborated with engineering on maintaining all infrastructure and compliance documentation for the facility for the purpose of maintaining regulatory compliance with Contractual, Procedural, Federal, State or Local law requirements.
- Collaborated with manufacturing engineers to resolve manufacture, process, and quality issues.
- Perform root cause investigation on non-conforming materials, RMA's and provide feedback to engineering for quality improvements.
- Proactively provided feedback to management and engineering regarding production process, quality, and workmanship issues.
- Support and oversee the cleaning team's training compliance program along with the review of corresponding training curricula.
- Trained personnel and enforce strict adherence to the applicable documents and SOP's of the Quality System.
Process Quality Technician - MITAC Information Systems Corp. - Newark, CA
(2020-01 - 2021-12)
- Worked with a cross functional team (manufacturing engineering, program management, supply chain, production) as well as customer to improve process and drive product quality.
- Assisted Engineering for Quality Concerns (Internal, Customer) and associated technical investigation, including management of analysis as required.
- Primary point of contact for all Quality related issues: assessments product failures, returns, technical issues, process issues, corrective actions.
- Collaborated with the Process Engineer along with the quality engineer on the collection of quality Data.
- Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis.
- Collaborate with manufacturing engineers to resolve manufacture, process, and quality issues. Perform root cause investigation on non-conforming materials, RMA's and provide feedback to engineering for quality improvements.
- Supported Engineering with CAPA and complaint investigations. Analyze root cause methodologies, implement containment, corrective actions and preventive actions.
- Reported and maintained appropriate quality metrics (KPI's),analyze quality performance and results across all customer products.
- Conducted weekly meetings to report findings and Corrective Actions for each customer product reported(RMA's).
- Performed assembly and mechanical inspections on different box build products.
- Trained personnel, and enforce strict adherence to the applicable documents and SOPs of the Quality System.
- Worked with manufacturing engineering to improve processes. This includes creating process plans, tooling and validations.
- Ensured that safe operating procedures were developed, communicated, and followed by all personnel.
Quality Technician - Philips IGT - Rancho Cordova, CA
(2019-01 - 2020-12)
- Monitor Quality Operations key performance indicators (KPI's) and support the compliance effort of the Quality team.
- Participated in continuous improvement activities by identifying opportunities and recommending improvements to development process.
- Proactively provided feedback to engineering regarding production process, quality, and workmanship issues.
- Performed periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
- Participated in procedure updates, assuring new items and updates were incorporated in the local QMS in a timely manner.
- Participated with production teams to manage non-conforming product and to drive cost of non-quality reductions.
- Primary point of contact for all Quality related issues: assessments product failures, returns, technical issues, process issues.
- Participated on first article inspections to ensure compliance of procured parts and materials (dispositioning non-conforming product as necessary).
- Managed that all Device History Record documentation are correct / complete and provide metrics and analysis to management as needed.
- Interface with Engineering, Quality, and Production to communicate quality standards and address issues in a timely manner.
- Trained personnel, and enforce strict adherence to the applicable SOP's of the Quality System.
Manufacturing Quality Lead - Advantest Inc. - San Jose, CA
(2018-01 - 2019-12)
- Conducted audits to ensure the organization's Quality Management System conformed to customer requirements, internal ISO 9001, ISO 17025, and regulatory/legal requirements.
- Supported Engineering in Identifying and implementing effective process control systems to support the development, qualification, and on-going development of products to meet or exceed internal and external requirements.
- Primary point of contact for all Quality related issues: assessments product failures, returns, technical issues, process issues.
- Assisted Engineering in the investigation and reduction of quality issues and follow-up with corrective actions.
- Responsible for maintaining, facilitating, and tracking various quality system components such as Material Review Board (MRB), Customer Corrective Action (CCA) system, Internal and External Corrective Action Request (CAR).
- Collaborated with engineering to manage the NPI SOP instructions to ensure the document showed the correct process steps and components used to manufacture the final product. Conducted audits and facilitated 8D corrective actions to ensure compliance with ISO9001.
- Performed root cause investigation on non-conforming materials and provide feedback to engineering for quality improvements.
- Proactively provided feedback to management and engineering regarding production process, quality, and workmanship issues.
Quality Lead - HPE - Roseville, CA
(2016-01 - 2017-12)
- Conducted assessments and evaluations through analysis and interpretation of objective and subjective evidence to verify compliance to standards and applicable quality plans. Developed written reports of findings; escalates unresolved issues to appropriate management levels.
- Developed and maintained quality assurance documentation for projects and tasks to include quality metrics. Ensured documentation complies with development standards, policies and procedures or best practices.
- Assisted management defining and maintaining an effective and efficient quality program including developing and presenting associated training and familiarization to affected staff.
- Assisted Engineering by reviewing and validating data integrity in reporting systems while supporting established quality standards, performing quality analyses, inspections and root cause analysis.
- Created and delivered relevant ongoing communications and metric scorecards to respective management, and team leaders.
- Reviewed and monitored the effectiveness of various processes through the retrieval and analysis of data.
Technician Lead - Sony - San Jose, CA
(2014-01 - 2016-12)
Image Sensor Design Center, ISDC
