RICHARD KNIESNER (408) 398-3990 / (408) 248-8999 611 Lisa Wy., Campbell, CA kr130f968@westpost.

net OBJECTIVE Take on a challenging role developing and implementing effective Quality Systems that contribute to the overall success and growth of the organization. SUMMARY Over 25 years experience in Quality, Operations and Engineering fields in the Hi gh Tech and Medical Device Industries: * Global supply chain management aligned to meet tactical and strategic objectiv es. * Certified ISO 9001, ISO 13485 and 21CFR820 Lead Auditor conducting supplier a udit qualifications and assessments. * Establishing effective quality systems and driving continuous improvement prog rams to achieve Six Sigma Quality. * Program Management, driving CFT performance to meet KPI's, customer timelines, and P & L. EXPERIENCE Boston Scientific Sr. Supplier Quality Engineer, Corporate SQM Fremont, CA 10/2006 - 10/2010 * Conducted global supplier assessments to meet ISO 9001, ISO 13485, ISO 14971 a nd 21CFR820 requirements and regulations. * Worked closely with Design Engineering and suppliers to ensure successful new product launches. * Worked with suppliers on the production qualification process to approve all n ew products, including developing quality plans, first article approvals and Cpk analysis for critical parameters. * Work closely with suppliers to investigate root cause and develop robust corre ctive actions to prevent recurrence. * Worked on commodity teams with Global sourcing to identify preferred suppliers . * Managed various supplier quality activities and regulatory affairs relating to supplier changes across multiple BSC sites. * Developed preferred supplier validation processes. * Managed complaint handling, working with Manufacturing Engineering / Product a nd Process Quality Engineering to determine root cause and develop robust correc tive actions to prevent recurrence. * Lead the Harmonization Project to align and standardize all Quality System Pro cedures between Santa Clara and Puerto Rico prior to production transfer for the Cardiac Surgery Division. * Developed a Quality Plan to define all the specific elements / timelines requi red to accomplish a seamless transfer. Tecan Systems San Jose, CA. 10/2004 - 8/2006 Sr. Quality Engineer * Reviewed and approved Design Documentation including Design Specifications and Product Requirements Documents. * Implemented Quality Plans for new products / materials which included process flow charts, DFM checklist, approved first article reports, manufacturing proces s instructions, inspection and test procedures, sampling plans, and process capa bility studies for all critical parameters. * Managed Complaint handling, including root cause analysis to drive continuous improvements efforts. * Performed Risk Analysis / FMEA's on all new products prior to design transfer to ensure Regulatory Compliance.

* Championed MRB process improvements in support of Management's commitment to s ignificantly reduce MRB inventory and cycle time (within 2 month MRB was reduc ed from > $100K to < $5K, and the average cycle time improved from 3 weeks down to 48 hours). * Managed the CAPA process, including root cause analysis and corrective actions to prevent recurrence. Cordis / Johnson & Johnson San German, PR 7/2004 - 9/2004 Quality Consultant (Quintech) * Conducted validation assessment and remediation for equipment and facilities i nstallation, operation, and process qualification activities in response to a FD A warning letter. * Completed IQ, OQ, PQ checklists to identify gaps within the process validation process. * Compiled data and presented major / minor gap assessment to the high level man agement team. BD Biosciences San Jose, CA.

2003 - 2004 Sr. Supplier Quality Engineer * Coordinated various NPI qualification activities including design verification , first article approval, process capability studies, and product and process va lidation testing (IQ, OQ, PQ). * Defined inspection instructions, and accept / reject criteria for receiving in spection. * Set up real time SPC data collection to monitor critical process parameters / characteristics as a tool to quickly identify any shifts within the process and drive continuous improvement efforts. * Worked concurrently with Product Engineering to address any design issues foun d during the NPI phase and coordinate the necessary recovery plans. Solectron Corporation Milpitas, CA. 1995 - 2001 Sr. Supplier Quality Engineer / Sr. Quality Engineer * Conducted supplier assessments in compliance with ISO 9000 / 13485, GMP, and Q SR/FDA regulations necessary to qualify and evolve a world-class supply chain fo r Solectron's High Volume Systems Division. * Supported several major OEM programs including medical devices from new produc t introduction throughout high volume manufacturing. * Took on a Program Management role in support of a specific program to satisfy a customer request. *Actively involved in seamless program transfers to Mexico and Asia. * Established KPI and SPC metrics that received high visibility and evolved to f orm weekly continuous improvement team meetings, addressing major issues, tracki ng open action items, due dates, etc., setting the standard for all programs acr oss the division. * Re-engineered various processes that demonstrated improvements in greater effi ciency and lower DPM levels. * Successfully completed a "Six Sigma Project" assignment resulting in savings t otaling more than $92K a month in rework, scrap, and material cost associated wi th a high volume program. * Directly managed all inspection personnel, providing leadership on various tac tical and strategic objectives. Sun Microsystems Inc. Mountain View, Ca. 1986 - 1994 Supplier Quality Engineer * Performed Global supplier selection and certification for external manufacture rs.

* Coordinated overall preparation for ISO 9001 certification. * Significantly reduced cost and headcount by eliminating incoming / source insp ection and incorporating an effective "Dock to Stock" process that resulted in a "Quality Achievement Award". * Defined scorecard criteria to kick off "Quarterly Reviews" evaluating supplier performance on Quality, Delivery, Responsiveness, Process Technology, and Price , to indicate overall Total Cost of Ownership. * Developed a DFM checklist for new product introduction to evaluate and resolve DFM issues with Product Engineering prior to production release. * Worked closely with suppliers to identify various areas for reducing cost and lead time, and improve logistics. * Approved supplier first articles, engineering changes, tooling changes, and pr ocess capability studies. * Worked with suppliers to develop quality plans and enhance process controls, a nalyzing Cp, Cpk, and histograms. Candela Electronics Sunnyvale, Ca. 1984 - 1986 Manufacturing Engineer * Successfully set up and managed a turnkey process at two suppliers, while stil l achieving an aggressive production ramp schedule of 10,000 units in the first month. * Reduced cycle time more than 30% in order to meet aggressive customer ramp pla n by supplying adequate data to justify reduced burn-in time while continuing to improve customer yields. * Conducted elemental time studies to provide proper line balancing and improve cycle time/takt time. * Maintained Manufacturing Process Instructions, Visual Aids, and Multi-Level BO M structures. Apple Computer Corporation Fremont, Ca. 1981 - 1984 Supervisor, Receiving Inspection * Set up Receiving Inspection department for New Products Division. * Provided training for inspectors on CMM and geometric tolerancing principles. * Developed inspection instructions for all incoming material. * Prioritized daily work schedule to accommodate production schedule. * Chaired MRB meetings to disposition discrepant material in a timely manner. * Presented Engineering and Management with yield data for various commodities. EDUCATION / TRAINING: Foothill College Los Altos, CA. -Electronics Other Applicable Technical Training: - ISO 9000 / 13485 Lead Auditor Certification - SPC - DOE - Kaizen - FMEA - AutoCAD / ProE - Lean Manufacturing - GD&T - Supplier Management - Demand Flow Technology - APICS - Design Requirements - Hoshin