San Diego County, California, United States
LEAD IMPLEMENTATION ON QUALITY SYSTEMS, SUPPLIER QUALITY AND REGULATORY COMPLIANCE Comprehensive background establishing and maintaining Quality management systems for commercial, Consumer Goods, Defense, Semiconductor, Automotive and Life Science sectors. Known as an expert for ensuring site readiness for QMS and Regulatory Audits in high-technology manufacturing environments. Strong Management, communication and people skills with demonstrated success supporting multiple manufacturing sites. Experience with Development and Implementation of Operational Excellence programs. Recognized mentor and trainer for Quality tools, problem solving/Root cause analysis. Information: [email protected]
Responsible of developing and implementing a compliant and cost-effective quality management system that assures products and services are reliable and safe, including continuous improvement projects, ISO 9001, calibration, customer investigations and other improvement activities. Collaborating with the VP of Operations, VP of Engineering, VP of Sales, and VP of Product Management to ensure Vendors, and products are held to the highest quality standard that AMETEK Programmable Power demands.
AMETEK Programmable Power’s products serve a wide range of stimulus (T&M) and process power needs in applications including semiconductor fabrication, commercial and defense ATE, oil exploration, solar array and battery string simulation, avionics, general R&D and EMC compliance testing.
Responsible for Operations in the supplier quality department. Perform supplier quality audits, assisting suppliers to solve reliability problems and ranking suppliers for development . Management of Domestic and international suppliers. Monitor the quality of manufactured components and products.
Responsible of new supplier development program, Improvements on exiting supplier's base performance in accordance to the highest quality standards in the industry. Assist supplier to improve product reliability
Responsible of new supplier development program, Improvements on exiting supplier's base performance in accordance to the highest quality standards in the industry. • Drives supplier quality improvements with the use of Problem Solving, Lean Manufacturing and Six Sigma methodologies/techniques. • Manage key supplier audit program (domestic and overseas) and responsible for the new supplier onboarding process (Quality system requirements and qualification)
Lead implementation of processes and indicators to meet quality standards base on ISO9001:2008 and CE, UL, Refrigeration PED, Low voltage metrics and machinery directive including the key business tool for operations performance at Brooks Life Sciences sites in USA, Manchester UK and Switzerland to deliver high technology Sample storage systems • Implemented incoming inspection area, supplier selection process and control of non-conformance material, including hiring, mentored and managed performance of QA staff. • Served as active participant on design reviews, engineering change orders approvals. • Developed validation plan for Pharmaceutical consumables, including IQ, PQ, and OQ in compliance with ISO 13485, resulting in successful tool refurbish program. • Directed Field failure complaint investigation and Warranty, FA’s 8D’s, 5W, FACAR’s, improving customer experience and problem resolutions. • Supported implementation of Business tools, MRP-Oracle, APL-Agile, HQMS, and Evolution (Training Global Web system), resulting in successful integration.
Management of quality and manufacturing engineer team supporting, delivery issues resolution, supplier quality, technical in house Quality support and product new launch activities. Effective identification, escalation, containment and resolution of field product quality issues. • Provided effective identification, escalation, containment and resolution of field product quality issues, resulting in 40% reduction in Out of the box quality. • Oversaw manufacturing controls obtaining ISO9001:2008 And PED, Category 2 certification for manufacture and service of refrigeration systems and vacuum coils. • Performed overseas quality supplier audits, contributing up to 20% savings on sheet metal commodity. • Received North Start Key strategy Award May 2013 in recognition of contributions to NPI cost reduction.
Supported Quality assurance and Supplier quality qualification activities during the Startup of Monterrey facility including the effective QMS implementation and achieving the goal to ship Finish good after customer audit and SSQA qualification. • Facilitated improvement road map, SSQA Audit Score > 6.0. • Achieved ISO9001:2008 Surveillance Audit and ETL-audit passed without findings. • Oversaw copy exact (control of changes) internal / external compliance.
Managed Process engineering activities required for startup of the PCB backend process at Monterrey Facility including Stamping /routing process validation/qualification and continues improvements.
Managed Manufacturing Process Engineering activities including New product introduction/ Run & Rate , PPAS, PFMEA, GR&R, Yield, Task Time, Kanban setting, JIT Glass Bending, Coating, Grinding and Cutting process