Summary:Provide quality management and leadership to all employees of the Markham business unit to exceed customer quality expectations.Details:Successfully led ISO 9001/13485/14001 audits by external registrars of our Quality and Environmental Management Systems and completed CAPA responses to address non-conformances.Provided leadership, coaching and training to team of 3 Quality Engineers and 1 Quality Technician to ensure KPI’s and customer satisfaction were… Show more Summary:Provide quality management and leadership to all employees of the Markham business unit to exceed customer quality expectations.Details:Successfully led ISO 9001/13485/14001 audits by external registrars of our Quality and Environmental Management Systems and completed CAPA responses to address non-conformances.Provided leadership, coaching and training to team of 3 Quality Engineers and 1 Quality Technician to ensure KPI’s and customer satisfaction were achieved.Created internal QMS audit schedule, participated in internal audits, and ensured completion of the audit plan.Reported on quality metrics to senior leadership during monthly performance reviews and identified action plans to address off-target KPI’s Show less

Summary:Responsible for strategic initiatives to improve product quality for the Markham business unit and for providing leadership to Quality Engineering peers.Details:Prepared and presented quality metrics to senior leadership and part of monthly business unit performance reviews. Led weekly reviews of internal quality defect data with cross functional teams to identify root causes and associated improvementsCo-hosted ISO 9001/13485 audit of our Quality… Show more Summary:Responsible for strategic initiatives to improve product quality for the Markham business unit and for providing leadership to Quality Engineering peers.Details:Prepared and presented quality metrics to senior leadership and part of monthly business unit performance reviews. Led weekly reviews of internal quality defect data with cross functional teams to identify root causes and associated improvementsCo-hosted ISO 9001/13485 audit of our Quality Management System (QMS) with external registrar including site tour, presentation of appropriate QMS procedures, facilitation of discussion with appropriate functional leaders, and formal responses of non-conformances raised.Mentored quality engineering peers with various challenges including effective corrective action strategy, management of customer complaints & expectations, and NPI responsibilities. Show less

Summary:Responsible for delivered product quality to 3 customers, for internal quality improvement projects to meet various KPI's, and for ensuring Quality Management System compliance to ISO 9001, 13485 and 14001 standardsDetails: Provided quality engineering support to customers including NPI/production support, quality reporting, and corrective action implementationPrepared and analyzed quality data including DPPM, FTPY and DPMO to identify priorities for improvement… Show more Summary:Responsible for delivered product quality to 3 customers, for internal quality improvement projects to meet various KPI's, and for ensuring Quality Management System compliance to ISO 9001, 13485 and 14001 standardsDetails: Provided quality engineering support to customers including NPI/production support, quality reporting, and corrective action implementationPrepared and analyzed quality data including DPPM, FTPY and DPMO to identify priorities for improvement effortsUsing DOE methodology, completed a project to identify the best label material and printing method for the Markham business unit to eliminate un-scannable barcodes during production.Demonstrated ability to collaborate with other engineering disciplines to understand and resolve real-time manufacturing quality issues.For more than 10 years, have conducted internal audits of our QMS to ensure compliance to ISO 9001, 13485 and 14001 regulatory standards.Utilizing the SCAR process, worked with suppliers to resolve recurring quality issues Show less

Summary:Responsible for production employees and for managing elements of the customer relationship to ensure timely delivery of customer products from prototype to production stagesDetails:Provided leadership to up to 30 employees and 3 production team leads including weekly team meetings, communication of production plan and expectations, annual reviews, conflict resolution, and disciplinary actions.Reviewed forecast requirements with customers and determined… Show more Summary:Responsible for production employees and for managing elements of the customer relationship to ensure timely delivery of customer products from prototype to production stagesDetails:Provided leadership to up to 30 employees and 3 production team leads including weekly team meetings, communication of production plan and expectations, annual reviews, conflict resolution, and disciplinary actions.Reviewed forecast requirements with customers and determined appropriate MRP system load to enable timely execution of material purchases and production buildsResponsible to ensure adequate staff available to meet customer demands and quoted profitability targetsPrepare and present revenue commitments & forecast, RMA status, on-time shipment metrics and potential delivery risks in weekly operations meeting to leadership teamParticipated in multiple Kaizen events including work cell layout improvements, SMT quick change-over, wave throughput, and standard work implementation. Show less

Summary:Responsible for monitoring, reporting and implementation of improvement actions for 3 different customers to ensure quality targets were achievedDetails:Generated monthly quality reports in compliance with customer requests including FPTY, Pareto charts, detailed root cause and corrective action findings.Monitored prototype SMT builds to resolve technical concerns and resolve design and process defects before promotion to production status.Responsible for… Show more Summary:Responsible for monitoring, reporting and implementation of improvement actions for 3 different customers to ensure quality targets were achievedDetails:Generated monthly quality reports in compliance with customer requests including FPTY, Pareto charts, detailed root cause and corrective action findings.Monitored prototype SMT builds to resolve technical concerns and resolve design and process defects before promotion to production status.Responsible for investigation and closure of corrective actions to remedy various customer quality issues.Participated on internal regulatory audit team to ensure compliance with company ISO quality policies & procedures Show less

Summary:Worked with customer to understand and improve the quality of their productsDetails:Engaged with customer’s engineering, quality, and service personnel to understand product usage environments, identify lessons learned from previous products, and develop appropriate verification test protocols.Analyzed field failure data to trend common failure modes, identify and initiate supplier quality improvement efforts, and implement appropriate process and design… Show more Summary:Worked with customer to understand and improve the quality of their productsDetails:Engaged with customer’s engineering, quality, and service personnel to understand product usage environments, identify lessons learned from previous products, and develop appropriate verification test protocols.Analyzed field failure data to trend common failure modes, identify and initiate supplier quality improvement efforts, and implement appropriate process and design improvements.Performed inspections of manufacturing cell to ensure finished products were assembled and tested according to the appropriate documentation and implemented procedural and product test changes to resolve issues.Resolved circuit board contamination issue responsible for manufacturing yield issues and field failures through the use of a 3rd party laboratory to identify root cause and implement corrective actions.Implemented improvements to the new product introduction process including cross-functional design reviews and increased software validation to eliminate repeat failure modes experienced by customer Show less

Summary:Designed customer & application specific computer chassis’Details:Utilized Solidworks modeling software and integrated sheet metal tools to design 7 new computer chassis assemblies for specific customer products. Introduced mechanical design capability for Dedicated Computing by creating a part numbering system & detailed drawing templates, implemented a supplier change notice process, and authored a mechanical standards document.Created guidelines and… Show more Summary:Designed customer & application specific computer chassis’Details:Utilized Solidworks modeling software and integrated sheet metal tools to design 7 new computer chassis assemblies for specific customer products. Introduced mechanical design capability for Dedicated Computing by creating a part numbering system & detailed drawing templates, implemented a supplier change notice process, and authored a mechanical standards document.Created guidelines and performed Highly Accelerated Lift Testing (HALT) utilizing vibration, shock, and temperature stresses to identify design improvement opportunities and validate design changes Show less

Summary:Designed mammography X-ray detector packaging and thermal management hardwareDetails:Collaborated with global design team to integrate product requirements and deliver new detector design with improved aesthetics and ergonomics. Designed interface plate used to secure detector casting to system positioner using SDRC-Ideas modeling software including completion of finite element analysis simulations to quantify deflection and stress margins.Utilized FEA… Show more Summary:Designed mammography X-ray detector packaging and thermal management hardwareDetails:Collaborated with global design team to integrate product requirements and deliver new detector design with improved aesthetics and ergonomics. Designed interface plate used to secure detector casting to system positioner using SDRC-Ideas modeling software including completion of finite element analysis simulations to quantify deflection and stress margins.Utilized FEA thermal simulation tools to identify feasibility of using an alternative thermal management subsystem within the mammography X-ray detector casting.Qualified casting and machining suppliers to produce X-ray detector parts by communicating design requirements, troubleshooting production problems, and quantifying finished part quality Show less

Summary:Managed qualification and reliability improvements of purchased environmental control sub-system for digital X-Ray detectorsDetails:Established effective and respectful working relationship with supplier to collectively improve supplier manufacturing processes and product quality.Provided engineering support to field service team in troubleshooting X-ray subsystem performance issues resulting in decreased customer downtime.Maintained design history files… Show more Summary:Managed qualification and reliability improvements of purchased environmental control sub-system for digital X-Ray detectorsDetails:Established effective and respectful working relationship with supplier to collectively improve supplier manufacturing processes and product quality.Provided engineering support to field service team in troubleshooting X-ray subsystem performance issues resulting in decreased customer downtime.Maintained design history files consisting of product life cycle documents including purchase specification, verification and validation plans, procedures, and results to assure regulatory compliance.Trained supplier staff with six-sigma statistical tools as a means to improve manufacturing processes and overall product quality.Developed test fixture that cost less than $250 to quantify thermal cooling performance of X-ray subsystem chiller to assure compliance with performance requirements Show less