Quality Systems Manager 2009 to June 20, 2014:• Maintained the company’s ISO 9001 & ISO 13485 Quality Management Systems; providing training and follow-up to ensure effective compliance.• Researched the requirements of governmental regulations, industrial standards, and customer specifications and quality agreements; implementing new programs and processes as required.• Managed the CAPA, Internal Audit, and Customer Feedback systems and led the Management Reviews and monthly Quality… Show more Quality Systems Manager 2009 to June 20, 2014:• Maintained the company’s ISO 9001 & ISO 13485 Quality Management Systems; providing training and follow-up to ensure effective compliance.• Researched the requirements of governmental regulations, industrial standards, and customer specifications and quality agreements; implementing new programs and processes as required.• Managed the CAPA, Internal Audit, and Customer Feedback systems and led the Management Reviews and monthly Quality Team meetings.• Designed and implemented a risk based system for approval and control of suppliers. This program separated the supply base into multiple levels with cost effective control systems appropriate to each supplier’s impact on confidentiality and the quality and safety of our product. Led supplier audits as required. • Designed and implemented the system for validation of non-verifiable processes and qualification of equipment.Senior Quality Engineer 2000 to 2009• Interpreted engineering drawings, methods, and specifications; then designed gages and developed plans for inspection, testing and evaluation of product to maximize product reliability and minimize costs.• Programmed CMM’s. Developed techniques for family table programs that allowed a single program to measure different size family members or measure the same part against different standards at various stages of production.• Directed and supported quality technicians and other associates engaged in inspection and testing activities to ensure continuous control over materials, facilities, and processes.• Tested and inspected products at various stages of production, compiled and evaluated statistical data to determine and maintain quality and reliability of product. Show less

• Responsible for hiring, training, and supervision of the QA and Shipping/Receiving staffs.• Responsible for the purchase of all inspection and testing equipment. I ensured that this equipment was sufficient for current demand and anticipated future needs. I trained all relevant associates in its proper use and designed and maintained a MIL-I-45662 Calibration System to ensure its continued acceptability.• Designed and implemented a MIL-I-45208 system for receiving, first article… Show more • Responsible for hiring, training, and supervision of the QA and Shipping/Receiving staffs.• Responsible for the purchase of all inspection and testing equipment. I ensured that this equipment was sufficient for current demand and anticipated future needs. I trained all relevant associates in its proper use and designed and maintained a MIL-I-45662 Calibration System to ensure its continued acceptability.• Designed and implemented a MIL-I-45208 system for receiving, first article, in-process, and acceptance inspection. This system was routinely audited and approved by our customers.• Designed and maintained the Material Safety Data System. This included controlling the flow of all hazardous materials into the shop, keeping current MSDSs for those materials on file, and training all associates in proper handling techniques.• Designed an ISO-9002 level system to control the flow of external documents.• Designed a system to monitor the process instructions, incorporate the requirements of customer purchase orders, specifications, and drawings, establish inspection requirements and instructions, and eliminate bottlenecks before the commencement of production.• Established a Process Engineering program to eliminate tolerance stacking and monitor critical variations in process. This system ensured conformance to customer specifications by breaking down each requirement into individual components, each of which was controllable. Each component was then monitored individually.•Designed jigs and fixtures to ensure conformance to unusual geometric requirements.•Trained and advised production employees in the mathematics needed to achieve customer geometric requirements and program CNC equipment.•Designed a classification system to monitor partially completed products that allowed efficient use of customer supplied material over multiple designs.•Designed the Continuous Process Improvement system and interacted with customers on quality issues. Show less