Phone 916-***-**** firstname.lastname@example.org
A responsible position where my skills in Quality Assurance, Process Engineering and Management can be utilized. QUALIFICATIONS: Extensive Professional engineering experience in lead-frame manufacturing, Electronic Manufacturing Services (SMT, Cable Assemblies, Box Build) in Semiconductor (Design, Process, Quality) with proven skills in the following areas:
Planned and led two companies through successful ISO 9001 registration
Streamlined/optimized the manufacturing flows of the RMA Process resulting in reduced cycle times.
Brought two companies from low rated supplier to top 10% with major customers.
Developed and implemented automated processes as a company employee.
Improved on cycle time closure of internal and external CAPAS from 70% to over 95% within a one-year period
Implemented and maintained an inspection process (Incoming, In-process final and out of box) for two companies.
Strong written and verbal communication and presentation skills and ability to influence others
Solid interpersonal skills and ability to effectively work with peers, both internally and with customers
Detailed knowledge of relevant quality standards (ISO, IPC, etc.), manufacturing processes, and process controls
Quality Engineer 2018 to Present
Philips IGT - Rancho Cordova, CA
Monitor Quality Operations key performance indicators and support the compliance effort of the Quality team
Provide ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes, and CAPA investigations.
Participate in continuous improvement activities by identifying opportunities and recommending improvements to development process.
Effectively worked with all levels of management to ensure CAPA action plans were supported and that costs/resources needed to implement the plan were available.
Performed periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
Participate in procedure updates, assuring new items and updates were incorporated in the local QMS in a timely manner.
Participate with production teams to manage non-conforming product and to drive cost of non-quality reductions.
Perform first article inspections to ensure compliance of procured parts and materials (dispositioning non-conforming product as necessary).
Analyze statistical data and product / process performance and to recommend and assist in the implementation of improvements in targeted areas of the organization.
Manage 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
Project Lead 2018 to 2018
Advantest Inc. San Jose, CA
Responsible for the development, implementation, and maintenance of the Design Department Quality Management System.
Conducted audits to ensure the organization's Quality Management System conformed to customer requirements, internal ISO 9001, ISO 17025, and regulatory/legal requirements.
Led in the implementation of quality systems processes, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Identified and implemented effective process control systems to support the development, qualification, and on-going development of products to meet or exceed internal and external requirements.
Led in the investigation and elimination of causes of quality problems 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).
Managed 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 8Dcorrective actions to ensure compliance with ISO9001.
Quality Engineer 2016 to 2017
HPE Roseville, CA
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.
Reviewed and validated 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.
Project Lead 2014 to 2016
Image Sensor Design Center, ISDC, Sony San Jose, CA
Managed a team in the Implementation of ISO9001:2008 Quality Management System in three facilities (San Jose, CA. Rochester, NY & Israel).
Developed training program for internal quality personnel and successfully trained more than 50 employees on ISDC Quality Management System and ISO 9001 with an ongoing organization.
Coordinate / Managed Quality Management Systems and processes for 3 facilities, managed a team to successfully pass an internal audit conducted by ISBU Sony (Japan) and a pre-assessment audit (ISO9001) conducted by a third party.
Implemented a quality system database (SharePoint) features included: Corrective Actions (Internal & External), Audits, Training, and Document Control.
Developed / Managed Compliant ISO 9001:2008 Policies, Procedures & Work Instructions.
Interfaced with Quality Management at ISBU(Japan) to ensure the design process flow at ISDC match their process.
Created, reviewed and updated all internal procedures to ensure it met Customer and ISO Standards. Chairperson for weekly quality meetings and provided QMS updates during management staff meeting.
Partner with Management to ensure the Quality Manual was current, appropriate and utilized throughout the company. Maintained all quality performance metrics for the organization and presented monthly to senior management.
Staff Quality Assurance Engineer 2010 to 2014
Entropic Communications San Diego, CA
Managed the QMS System, ROHS, REACH and Conflict Minerals efforts to ensure the company was in compliance with the regulatory requirements in all products.
Developed / Managed Compliant ISO 9001:2008 Policies, Procedures & Work Instructions, proactively improve the quality system of the company through internal audits, participation in process improvements programs and interaction with all customers to obtain their feedback.
Managed / Responded to Corrective Action's: Internal, Customer, and / or Supplier Initiated / Solicit internal feedback regarding corrective and preventive nonconformities via the Quality CAR/PAR Program.
Coordinated Process / Product Change Notice (PCN) for internal/external changes Prioritized customer interface with respect to quality issues and complaints, provided follow-up measures and updates; facilitating relevant resolutions in time and keeping customer satisfaction.
Responsible for scorecard management reviews and applying corrective actions to manage the customer scorecard to ensure positive ratings for our products.
Audited the quality system for deficiency identification and correction. Leads resolution to complex and diverse problems by providing guidance and direction to quality, product, software engineering and technical staff.
Supported Process and Test Engineers and Program Managers with customer interface as necessary on quality related issues.
Created, reviewed and updated all internal procedures to ensure it met Customer and ISO Standards.
Managed outside accreditation body audits by coordinating with internal process owners and interfacing with interested parties.
EDUCATION AND TRAINING
BS: Industrial Technology, Business Management
San Jose State University San Jose, CA.
Strong PC skills with proficiency in MS Office (Word, Excel, PowerPoint).
Excellent organizational skills, documentation ability, attention to detail.
ISO 9001, CMMI level 3, AS9100, IPC 610, ISO13485, GR&R, CE Mark, CSA, RoHS, REACH.
Customer & Supplier Interface. Interpret Customer Drawings.
Technical review of customer specifications. RMA, MRB, NCMR, SOP, NPI, CAPA, SAP.
Certified Internal Auditor (RAB). First Article Inspection Reports (FAIRs).
Training Supervision. In coming, in process, Final Inspection initial set up.
Customer / Supplier Corrective Action (8D). Stamping, Plating, Etching Process.
Strong solid skills in First Article Inspection Reports (FAIRs), in coming, in process, Final Inspection set up. Stamping, Plating, Etching Process.