George D. McConnell 1111 Morse Ave. # 110
Sunnyvale. Ca. 94089
408-747-0825
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OBJECTIVE To contribute to the efforts of a progressive and growth oriented company in a Quality Engineering position. QUALIFICATIONS - A Quality professional highly experienced in resolving quality issues with a wide variety of products and technologies.
- Development of quality assurance programs, policies, processes & procedures in compliance with ISO, FDA and other requirements.
- Training and certification in ASQ Quality System Regulation Course for Medical Devices FDA regulations CFR21 Parts 820, 210, 211, and Part 11.
- Evaluation, qualification, & management of contract manufacturers by means of detailed system and process audits.
- Excellent oral and written communication & Interpersonal skills
- Conversant with ASTM, ASME, ANSI, FDA, AWS, Mil-Q-9858 and other military specifications
- Experienced in MS Word/Excel/Access/Power Point, Visio, Documentum, Oracle and various MRP systems
PROFESSIONAL EXPERIENCE GDM Quality Engineering Services, Sunnyvale, Ca. 01/07 - Present
Idependent Quality Engineering consultant providing consulting services to a variety of clients in the medical device & Hi tech industries. The services provided include: ISO9001-2000 Transition, WEEE/RoHS Compliance, Internal ISO, FDA, 13485 Auditor Training, IPC Training, Manufacturing process evaluation and improment, Supplier Development, Supply Chain Management, and Outsourced Supplier Quality Services. TechniPower Inc., 09/2006 – 11/03/06
1080 Holcomb Bridge Rd., Bld. 100, STE 250, Roswell, Ga. 30076
Quality Engineerinmg Consultant under contract to Excel Precision Inc., 3255 Scott Blvd., Bldg. 1, Ste 101, Santa Clara,, Ca.95054Responsible for upgrading Excel Precision’s Quality Management System and Process documentation. Evaluated and revised the Qulity Systems Manual a number of Operating and Process procedures to ensure that the QMS as now structured is prepared for the ISO or other regulatory certification whenever the company is ready to pursue that direction. Inventoried all current and previous QMS and business records in order to prepare a directory of the location of Records. GDM Quality Engineering Services, Sunnyvale, Ca. 08/2005 – 04//06
Independent consultant under contract to Boston Scientific EPT Division, Orchard Pkwy, San Jose, Ca. Responsible for upgrading BSCI’s Supplier Quality Assurance and Receiving Inspection processes. Evaluating strategic programs to ensure compliance with FDA, Corporate & Divisional requirements. Reviewing 1st Article Inspection records for adequacy as well as regulatory compliance Kelly Technical Resources, San Jose, Ca. 04/2005 – 06/2005
Quality Engineering Consultant under contract to Valley Electronic Services; San Jose, Ca. a Contract Manufacturer.
Analyzed and evaluated 40 specific components for assembly and testing performance characteristics in conjunction with a certification project directed by a Customer. Conducted Process FMEAs identifying & documenting critical RPN’s & Severity Levels. Performed statistical analysis of inspection data for assembly, soldering and testing performance in order to calculate component RTYs, DPMOs & Cpks, developed Yield Paretos, & Histograms AQSN Tularcitos Dr. Milpitas, CA 10/2003 – 3/2005
Quality Engineering Consultant: AQSN is a network of "Quality" resources that provide specialized consulting in areas of concentration that can be outsourced from within a company. The services we have provided include: ISO9001-2000 Transition, WEEE/RoHS Compliance, Internal Auditor Training, IPC Training, Supplier Development, Supply Chain Management, and Outsourced Supplier Quality Services. Additionally I successfully completed a 16 week certification Black Belt Workshop, in preparation for the ASQ Black Belt examination. During this time period, I have also trained and recertified as an IPC Trainer, successfully completed 2 Lean Manufaturing courses, and a Green Belt training program. Man-Power Inc., Santa Clara CA 04/2003 – 09/2003
Manufacturing Compliance Engineer: Consultant under contract to Abbott Laboratories, HPD; Morgan Hill, Ca. Conducted extensive process reviews of all manufacturing processes to identify & document any deficiencies and non-compliances with cGMPs, EN46000, ISO and other Divisional requirements. Performed detailed Gap Analyses and recommended solutions for implementing corrective/preventive actions in the Electronic Drug Delivery and Infusion Therapy product lines. Performed follow-up assessments of implemented corrective actions to ascertain their level of effectiveness. A total of 156 work instructions, test procedures, checklists, Logs, DHRs, and inspection instructions were revised during the project. Cylink Inc. Santa Clara, Ca 04/1999 – 03/2003
Senior Quality Engineer: Managed the Supplier Quality program for selecting, qualifying and managing contract suppliers of .precision machined parts, electronic circuit board assemblies, electronic components, cables and harnesses, sheet metal parts, and electromechanical subsystems. Revised company requirements to expand the supplier evaluation process and develop a partnership environment between Cylink and their supplier base. Performed internal system and process audits and coordinated the mplementation of corrective/preventive to eliminate non-conformities. Reduced reject rates by implementing improved inspection techniques and tools. Provided training in IPC requirements for Acceptance of PCBAs as well as ISO requirements & ESD Awareness for Cylink employees. Trimble Navigation Limited, Sunnyvale, Ca. 09/1997 – 11/1998
Senior Process Quality Engineer: Responsible and accountable for identification and resolution of manufacturing and process related issues for the Commercial Systems Group. Provided supervision and guidance in working with both manufacturing and process engineering personnel in Trimble's PCA Ops Division in improving the processes for assembly of PCBAs utilized by CSG. Directed the implementation of process changes. Revised the SPCA database and Defect Codes to more accurately identify adverse trends and initiated development of metrics for reporting process related performance to management during Quality System reviews. Contributed to a number of NPI Teams, the ISO and ESD audit teams and the Corrective Action Board. Also performed many of the same functions as shown above. C-COR Electronics Inc. Fremont, Ca. 09/1996 – 09/1997
Facility Quality Engineer: Managed the ISO Quality System, achieved a successful re-certification to ISO 9001 in 1997. Established, and managed a test department responsible for performance, environmental & compliance testing of the company’s products which reduced DOAs by 92%. Developed policies and procedures for the handling, serialization and reporting for Lasers in accordance with FDA’s CDRH requirements. Improved manufacturing practices and revised process related documentation that eliminated manufacturing defects and reduced 1st pass test failures by 34%. Orbitek Engineering Inc. Santa Clara, CA 08/1995 – 08/1996
Senior Systems Quality Engineer: Responsible for developing the ISO Policies & Procedures for certification to ISO 9001. Directed and counseled all departments in the development of ISO policies and procedures. Created policies and procedures for manufacturing processes for clean rooms and Orbital welding areas. ADDITIONAL EXPERIENCE Kenetech Windpower, Inc. Livermore, CA 09/1990 - 07/1995
Supplier Quality Engineer/Supervisor Managed SQEs responsible for assessment and management of all vendors. Quantic Industries Inc., San Carlos, Ca. 05/1988 - 08/1990
QA Engineer Responsible for ensuring compliance with all Product Assurance functions for multiple programs with contractual and military specifications. EDUCATION - B.S. in Business Administration equivalency from Dalmo Victor's Executive Training Program
- USN Aviation Electronics Schools Class A, B, & AVB, have been evaluated by American Council on Education. (being equivalent to an Associates degree in Electronics Technology)
- Training and certification in FDAs CFR21 Parts 820, 210, 211, and 11. Pro Match Career Resource Center. 1/26/02
- Completed ASQ ISO 13485:2003 Implementation and Transitioning of the QMS for Medical Device
- Organizations Course – ASQ Course # 618 04/08/2006
- Completed Ohlone College Quality System Regulations - Medical Devices Workshop - 06/05/2006
- Completed certification training in Complaint Handling, Medical Device Reporting – ASQ Course # 604 2/12/2005
- Completed Ohlone College Quality System Regulations - Medical Devices Workshop - 06/05/2006
- Completed Ohlone College Basic Statistics Workshop for QA/QC in Biotech Industries - 05/ 01/ 2006
- Completed Ohlone College Advanced Statistics Workshop for QA/QC in Biotech Industries - 05/ 08/ 2006
- Completed Ohlone College Workshop for Project Management & Product Development in the Biotechnology and Biopharmaceutical Industry - 05/ 11/ 2006
- Completed certification training in Quality Council of Indiana's 6 Sigma Black Belt Body of Knowledge - AQSN 09/06/04
- Attended BioDevice Group’s Seminar, “21 CFR Part 11: Using the Risked Based Approach to Safe Electronic Records”; 5/17/05.
- Training in Lean Manufacturing in High Variety / Low Volume Production Environments - ASQ Course # 608. 3/11/04
- Completed Certification Training in Lean Manufacturing for Production and Non-Production Environments - SVTI 8/27/04
- ISO 9000 Auditor Training, Stebbing & Partners International, KEMA # , TUV, NSAI, & BSA.
- Training & Certification as an IPC Instructor (CIT # 11817), STM Inc. 6/11/04
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