Sr. Quality & Systems Test Engineer with hands-on experience in electronic medical device testing in secured laboratories. Highly motivated team individual with excellent organization, communication, & technical problem solving skills. Proved track record of consistently handling multiple task demands to high levels of competence and integrity, while also meeting critical deadlines in minimally supervised environments. * Extensive knowledge of methods and process of medical device design control * In-depth knowledge of the concepts of engineering change control, statistical techniques, and IQ/OQ/PQ validation protocol * Familiar with FDA Quality System Requirements/ISO 13485, Six Sigma, quality auditing, and engineering drafting * Sound knowledge of Solid Works, ISO (ISO: 13485) regulations, Gage R&R, and Pro Engineering concepts * Well versed in communicating effectively with knowledge of basic computer applications * Hands on experience in testing quality of medical devices for various applications with sound knowledge of standard quality testing Fluidigm Corporation 7000 Shoreline CT #100, South San Francisco, CA 94008 (650) 266-6000 Sr. Quality Engineer: 1/1/2016 - Present * Create validation protocols, perform inspections and/or tests, analyze results & prepare summary reports * Document assembly, test, labeling, packaging, delivery, setup, installation, and servicing processes. * Audit suppliers and their quality system processes using FDA 21 CFR 820 and ISO 13485 requirements * Provide contributions to regulatory filings and to the Corrective and Preventive Action (CAPA) processes * Assisted in new product designs incl. risk assessment, design verification & validation testing (R&D & Mfg) * Write and review documentation (SOPs, Quality Instructions, protocols) related to quality control activities * Authored & managed ECOs, calibration, training, complaints, CAPA systems, & database tracking * Mitigated vendor defects through supplier corrective action processes as QA MRB committee member * Maintained Quality System in accordance with ISO13485, ISO9001, ISO17025, FDA QSR (21CFR:820) * Performed internal/external supplier audits to assess Quality System compliance & Improvement areas * Managed Equipment Calibration & IQ/OQ/PQ program Spine view Inc. Fremont, a Sr QA Engineer April 2013 to January 2016 * Work with R&D teams to develop manufacturing processes * Redesign existing manufacturing processes to reduce product cost and manufacturability. * Perform process capability assessments and establish methods to control process output. * Perform process validations, including generating protocols, reports and tracking status. * Provide engineering support to the manufacturing floor and resolve issues impacting production fulfillment (e.g. troubleshoot existing manufacturing processes, fixtures, tooling or equipment and resolving NCRs/ CAPAs). * Define, write, and update process specifications, process instructions, BOMs and travelers. DHR, LHR and Routers * Design, build or procure improved fixtures, tooling or equipment to increase quality, reliability, capacity, and yield. * Work with production team to ensure controlled environment room is well maintained, safe, and provides a suitable work environment for assembly operations. * Write and perform IQs, OQs and PQs when introducing new or changing existing manufacturing equipment. * Participated in and periodically lead efforts at updating risk documents, especially PFMEAs. * Provide engineering support to outside suppliers, ensuring quality and production targets are met. * Engineering design/re-design projects as needed, to maintain quality. * Evaluate vendors based on vendors' quality product performance, Material Review Board (MRB) meetings, and vendor on-site audits.

Highlights:

• Manufacturing
• Purchasing
• Documentation
• Audit
• Engineering
• Management
• Mechanical Engineering
• Quality Assurance