Manage 510(k) remediation activities for legacy medical devices.

Responsibilities include Supplier Corrective Action Requests, Supplier Initiated Change Requests, Component Analysis, NCRs, supplier metrics and production support.

CAPA / SCAR remediation project. Review previously closed CAPAs and SCARs to determine if adequate actions were taken. These actions include containment, root cause analysis, corrective and preventive actions, effectiveness verification and event reoccurrence.

Sole SQE for Moog Medical Devices Group, Salt Lake City site. Manage all supplier quality activities, including supplier audits (qualification, surveillance and process) globally, supplier corrective action requests, supplier scorecard and supplier related CAPA activity. Assist incoming inspection with analysis and disposition of incoming parts, as well as developing Inspection Criteria for incoming parts. Formulate and implement long term supplier strategies in conjunction with sourcing and engineering. Current supply base includes injection molders, extruders, contract manufacturers, electronics, wiring harnesses, machining and calibration. “Back Room” general for onsite FDA inspections. CAPA lead investigator. Member of internal audit team.Key Achievements: •Manage all supplier quality audit activities for the division; 65 critical suppliers in 14 countries. •Reduced the overall number of supplier corrective action requests (SCAR) from 85 down to 14 in a six month period. As a result of solid SCAR implementation under my direction NCR activity from the supply base was reduced by 36%.•Improved the overall supply base SCAR response time from 74% over 45 day response to only 8% over 45 day response.•Implemented a supplier scorecard system which evaluates and scores the supply base based on key performance indicators.

Design, develop, implement and manage supplier quality engineering activities for a mining products company with manufacturing sites in the USA, Canada, China, Australia, Poland and Germany. These activities included: global supplier quality system audit tool, supplier scorecard report, root cause & corrective action tool and supplier quality manual. Provide guidance and leadership in high profile supplier quality issues. Motivate and drive culture change for all supplier quality activities across the enterprise. Key Achievements: •Designed, implemented and executed a standardized supplier quality system audit tool for use globally.•Designed and implemented a root cause corrective action tool (8D basis); designed tool, trained quality personnel and suppliers in 6 separate countries.•Managed and drove to resolution multiple quality issues; investigated and discovered root cause, managed containment activities, developed and implemented corrective and preventive action activities.

Perform supplier qualification and surveillance audits IAW 21 CFR Part 820 and part Part 11, ISO 9001 and ISO 13485 guidelines. Manage a large and diverse group of suppliers in terms of quality metrics, on-time performance and open and honest communications. Assist suppliers in improving their quality management systems to better support the requirements of GE Healthcare. Manage the Supplier Corrective and Preventive Action process with my assigned suppliers. Lead internal GE Healthcare investigations in the role of lead investigator with the goal of reducing safety risks, improving product quality and assuring product compliance to FDA guidelines. Key Achievements: •Reduced the Defective Parts per Million metric of my assigned suppliers by 40% over a two year period resulting in a $1.6M savings.•Lead a cross functional team during an internal investigation resulting in a significant improvement to the safety and reliability of the x-ray tube used in the 9900 Elite X-Ray system. •Spearheaded a project with a supplier and GE Healthcare design engineering department to redesign a key system component resulting in an overall savings to GE Healthcare of $500K.

Develop and implement enterprise and divisional supply management strategies to define and integrate supply chains that support Enterprise Product Delivery Process (EPDP) and Enterprise Order Fulfillment Process (EOFP). Establish, build and maintain highly productive relationships with assigned suppliers to monitor and improve supplier performance. Measure performance and define corrective actions in collaboration with quality, product engineering and other functional representatives. Support supplier agreement negotiations in accordance with cost models, implementation strategies and technical specifications to meet overall goals for cost, quality and supply continuity. Team with design/manufacturing engineers regarding product specifications and make recommendations to suppliers. Lead DPAR activities with suppliers to drive out costs in new and existing components. Provide work direction and coaching to supply chain team members. Collect cost data and prepare analysis. Develop and implement continuous improvement procedures based on and driven by supplier performance. Key Achievements:•Improved overall profitability of facility by $3.2 million by leading 3 cross-functional teams in development and re-sourcing of 3 major assemblies to low-cost sources in China, India and Mexico.•Collaborated with existing suppliers to produce $750,000 in additional cost savings by improving efficiencies and part design and reducing waste, WIP and finished goods inventory, as well as reduced warranty claims. •Initiated new Production Part Approval Process to track submissions from suppliers and collaborated with IT department to develop custom SAP module to store data for easy retrieval, resulting in 30% data access time improvement. Developed guidelines, tested model and trained supply team in use. •Improved customer image by leading onsite demonstrations and Q&A sessions at local Lowe’s and Home Depot stores while showcasing equipment.

Managed all aspects of newly awarded contracts – from initial design to high volume finished production. Responsible for both electrical and mechanical design of custom power supplies. Designed, integrated and tested new systems for both military and commercial applications. Operated testing equipment such as oscilloscopes, multi-meters, EMI spectrum analyzers, temperature/humidity shock chambers and vibration tables. Supervised 12 assemblers and 2 lab technicians. Trained assemblers to certified soldering and assembly standards (IPC-A-610 & J-STD-001).Key Achievements: •Spearheaded 7 projects from conception to finished product ranging in value from $250,000 to $5 million. •Created complete BOM system, including manufacturing documentation process and finished product. •Developed and documented set of assembly and testing procedures for each project. •Established and managed in-house soldering certification program.

Developed inspection work packages for incoming aircraft according to specific maintenance procedures for amount of flight time per aircraft. Collaborated with aircraft manufacturing representatives to coordinate inspection procedures. Key Achievement: •Maintained high level of accuracy and attention to detail for critical measurements and technical documentation used as legal record of aircraft maintenance history.