Implemented ISO 9001:2015 Quality Management System. Certification achieved in November 2019. Implemented incoming inspection operation which included hiring one Lead Inspector, all required tool sets, purchase of CMM, purchase of Keyence Visual Inspection station. Prior to implementation of this operation all material went directly to stock resulting in a 90% WIP material reject rate. After development and implementation of inspection procedures and plans, rejection rate dropped by 30% within 5 months.Investigate all customer and supplier related issues and initiate CAPA’s or SCAR’s as needed and drive to resolution.Designed and implemented automated NCMR, SCAR, CAPA, and Issue Management system through Omnify PLM Quality Module. Prior to this no data collection took place and processes were on paper.Implemented automated Training program through Omnify PLM Training Module. No training records prior to this being implemented.Responsible for conducting supplier audits on critical supply base.Responsible for Internal Audit program.Participate in Design Review process.Implement and maintain corporate calibration program.

Responsible for all supplier quality activities for the Peabody and Canton MA., facilities. Support Analogic China SQE team as needed.▪ Provide direction on supplier quality strategy.▪ Analysis of supplier performance and continuous improvement efforts.▪ Plan and maintain supplier audit schedule and conduct audits per schedule.▪ Partner with purchasing to enhance supplier quality and to drive improvement efforts.▪ Review all supplier corrective action responses. Work with suppliers to enhance efforts to drive to root cause.▪ Evaluate all proposed supplier process and product changes.▪ Recommend design or test methods for achieving product and process improvements.▪ Work with suppliers on PPAP submissions for all critical components.

Responsible for all product and customer quality related activities.▪ Interfaced directly with TSA, BAA, CATSA, and FDA personnel to coordinate Factory Acceptance Testing, design reviews, program management reviews, and field problem resolutions.▪ Maintained Divisional Quality Management System and provided support for all ISO, internal, and third-party audits.▪ Developed and implemented in-process, final inspection, and final acceptance processes for all Explosive Detection Systems, Radiation Therapy Systems, and their associated spare parts prior to shipment to customers.▪ Developed Incoming Inspection product checklists and inspection methodologies.▪ Supported New Product Development and associated tollgates.▪ Developed Supplier Quality Plans for all EDS and RTS Critical Components.▪ Implemented Production Part Approval Process on all EDS and RTS Critical Components for New Product programs.▪ Quality representative for NPI, ECO, Reliability Improvement Teams and other customer-specific activities.

•Managed all Newington supplier quality functions, developing a world-class supply base that provided high quality products to schedule.•Developed and implemented Supplier Performance and Development Programs in order to reduce supplier defect levels.•Conducted supplier training in the 5 Principles of Problem Solving corrective action methodology and basic Statistical Process Control Techniques.•Partnered with Corporate Sourcing group on all outsourcing activities in order to reduce labor and inventory costs while improving efficiency and productivity.

•Managed all Woburn Manufacturing Quality, Customer Quality, Supplier Quality, and Calibration Services functions.•Prepared PPAP packages including Material Certifications, Process Flow Charts, Process Control Plans, FMEA, ISIR (Initial Sample Inspection Reports), Capability Studies, and Gage R&R/MSA/EMP studies.•Managed ISO 9001:2000 Quality System for the Woburn site.

•Managed 12 employees between two manufacturing sites, covering product quality, supplier quality, customer quality, and calibration services.•Established training programs in 5P, 8D, Root Cause Analysis, SPC, Process Control Methodology, Failure Mode and Effect Analysis (FMEA), Design of Experiments.•Implemented Control Plan methodologies throughout the manufacturing operation and wafer fabrication facility. Included: SPC, MSA studies, Process Mapping, Operational Definitions, and Out-of-Control Action Plans.

•Quality Project Lead on all commercial and medical manufacturing programs. •Developed Assembly Work Instructions and programs for Universal automated assembly equipment.

•Quality Project Lead on all commercial, medical and government manufacturing programs.

•Quality Project Lead on all commercial manufacturing programs.