• Formulate and manage the development and implementation of strategic goals, objectives, policies, procedures and systems pertaining to the QA/QC.• Promote quality achievement and performance improvement throughout the organization.• Develop, implement, communicate and maintain a Quality Plan that achieves the company’s quality objectives and is in compliance with customer and industry Quality Plan requirements.• Effectively interact with Production and Development teams to help… Show more • Formulate and manage the development and implementation of strategic goals, objectives, policies, procedures and systems pertaining to the QA/QC.• Promote quality achievement and performance improvement throughout the organization.• Develop, implement, communicate and maintain a Quality Plan that achieves the company’s quality objectives and is in compliance with customer and industry Quality Plan requirements.• Effectively interact with Production and Development teams to help introduce new products• Establish quality systems, processes, standards, requirements, documentation and inspection methods with external suppliers. Work with Purchasing staff to communicate and administer the supplier management systems while ensuring compliance with customer, industry, national and international standards and legislation. Maintain compliance with all quality certifications.• Define quality systems, procedures, processes and documentation in conjunction with Engineering, Plant Manager, Purchasing and operating staff.• Set up and maintain controls and documentation procedures.• Liaison with customers’ quality staff and auditors and ensure the execution of corrective action and compliance with customers’ specifications.• Monitor performance by gathering relevant data and producing statistical reports.• Identify relevant quality-related training needs and ensure training is delivered.• Ensure tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary.• Write technical and management systems reports.• Bring together staff of different disciplines and lead the group to plan, formulate and agree upon comprehensive quality procedures. Show less

• Collect, analyze, and summarize data in order to drive continuous improvement.• Develop & analyze data to support the development of new product specifications.• Using new product specifications, develop a method to assess new product quality & reliabilityprior to production release.• Maintain Calibration and Measurement systems used to assess product quality.• Ensure Customer Complaints are addressed, resolved and communicated to the customer in a timely manner. •… Show more • Collect, analyze, and summarize data in order to drive continuous improvement.• Develop & analyze data to support the development of new product specifications.• Using new product specifications, develop a method to assess new product quality & reliabilityprior to production release.• Maintain Calibration and Measurement systems used to assess product quality.• Ensure Customer Complaints are addressed, resolved and communicated to the customer in a timely manner. • Maintain Corrective and Preventative Action (CPAR) process to ensure Root Cause Analysis (RCA) and identified solution is in place and effective.• Ensure Supplier Corrective Action Reports (SCAR) are effective and resolved in a timely manner. • Provide and oversee Inspection activities for products throughout production cycle.• Collaborate with Department Managers to maintain & revise QMS documentation as necessary to maintain ISO 9001 registration. • Complete any Customer or 3rd Party Audit Corrective Action Requests in a timely manner.• Conduct Supplier and / or Internal Audits as needed.• Ensure effective communication of iAutomation’s Quality Policy to all personnel within company.• Develop and implement Quality Training programs. Show less

• Direct MRB activities including facilitating MRB, tracking non-conformances and analyzing NCMRs and RMAs. • Perform analytical investigations and develop root cause for non-conformances and deviations as identified through scrap analysis, NCMRs and RMAs. • Coordinate RMA process including approval, verification upon receipt, disposition and issuance of subsequent CAPAs. Respond to customer related SCARs as required. • Monitor supplier performance through scorecard/grading… Show more • Direct MRB activities including facilitating MRB, tracking non-conformances and analyzing NCMRs and RMAs. • Perform analytical investigations and develop root cause for non-conformances and deviations as identified through scrap analysis, NCMRs and RMAs. • Coordinate RMA process including approval, verification upon receipt, disposition and issuance of subsequent CAPAs. Respond to customer related SCARs as required. • Monitor supplier performance through scorecard/grading, analyzing RI measurement data (SQC) and tracking NCMRs. Perform supplier audits and visits as required. • Analyze data and generate reports from ERP data using Minitab and Excel. • Create validation protocols (IQ, OQ, PQ) execute protocols and document reports when required. Assist in DOEs, ANOVA and other analytical methods to optimize processes.• Develop, document and train inspectors using internal procedures and GD&T guidelines. Design/specify gauging and test equipment for inspectors.• Create/update RI & Final Product MIR cards for product inspection and testing. • Improve measurement techniques and detection methods using GRR, MSAs, and poke-a-yoke. • Communicate effectively with production associates to understand issues/concerns and quickly move to countermeasure.• Research and propose innovative documentation, training and inspection methods, including electronic record retention, automated visual inspection and inspector certification programs. Show less

• Customer Quality Champion for the Industrial Sensing Pressure Sensing lines.• Managing strategic customer accounts with direct customer interface to drive improvements in all aspects of Quality and continuous improvement.• Drive quality improvements impacting IS Pressure Sensing lines across multiple sites serving the Industrial market• Complete and maintain customer corrective action reports (8D’s) in a timely manner to meet deadlines• Work with Engineering and Technical… Show more • Customer Quality Champion for the Industrial Sensing Pressure Sensing lines.• Managing strategic customer accounts with direct customer interface to drive improvements in all aspects of Quality and continuous improvement.• Drive quality improvements impacting IS Pressure Sensing lines across multiple sites serving the Industrial market• Complete and maintain customer corrective action reports (8D’s) in a timely manner to meet deadlines• Work with Engineering and Technical colleagues in a team environment to manage key customer accounts for Quality in the Industrial market• Communicate with International make sites and Design Engineering to determine root cause and corrective action.• Communicate corrective actions from International make sites with key customers on returned goods • Generate supplier score cards to Key Industrial Sensing customers to meet their quality requirements and expectations.• Responsible of reporting out and addressing the Industrial 8D backlog Show less

• Customer Quality Champion for the Power Controls Hydraulic Magnetic Circuit Breaker lines.• Keep current with key customer issues and returns• Complete and maintain customer corrective action reports (8D’s) in a timely manner to meet deadlines• Involve Design and Manufacturing in the improvement of current processes and work instructions.• Communicate with International make sites and Design Engineering to determine root cause and corrective action.• Host weekly UL hold… Show more • Customer Quality Champion for the Power Controls Hydraulic Magnetic Circuit Breaker lines.• Keep current with key customer issues and returns• Complete and maintain customer corrective action reports (8D’s) in a timely manner to meet deadlines• Involve Design and Manufacturing in the improvement of current processes and work instructions.• Communicate with International make sites and Design Engineering to determine root cause and corrective action.• Host weekly UL hold meetings with Customer Service, Design Engineering, UL test laboratory, and International make sites to address status, pending orders, financial impact, action items, and containment plans.• Participate in SQDC (Saftey, Quality, Delivery, Customer) with International make sites on improvement projects, quality metrics, 8D backlogs, and customer CARE’s (Customer Action Response Excellence) • Communicate corrective actions from International make sites with key customers on returned goods • Generate supplier score cards to Key Power Control customers• Participate in COPQ (Cost of Poor Quality) reporting• Responsible of reporting out and addressing the Power Controls 8D backlog Show less

Recommend & implement continuous improvements: Cost and waste reduction, N. P. D. , & Product ImprovementPerform product quality assurance testingResolve production problems through identification, root cause, and problem correctionCreate quality control plans, test procedures, quality procedures, and trial plansConduct internal process audits monitoring S.O.C.’sControl outsourced processes for critical to quality machinery partsPlan, control, and assure product and… Show more Recommend & implement continuous improvements: Cost and waste reduction, N. P. D. , & Product ImprovementPerform product quality assurance testingResolve production problems through identification, root cause, and problem correctionCreate quality control plans, test procedures, quality procedures, and trial plansConduct internal process audits monitoring S.O.C.’sControl outsourced processes for critical to quality machinery partsPlan, control, and assure product and process quality in accordance to quality principlesAcquire and analysis production data and trial data to facilitate process improvementsDuPont STOP safety group leader Show less

Participate in continuous improvement efforts such as Lean Manufacturing Initiatives, value stream activities, kaizen events and Quality Improvement efforts (potentially including BIC).Conducting Internal Audits as directed by QA Supervisor.Use micrometers, dial/digital calipers, scales, height gages, optical comparitors, hardness testers, colorimeters, and any other equipment necessary to ensure visual conformance, form fit, and function, etc. in addition to using electrical and… Show more Participate in continuous improvement efforts such as Lean Manufacturing Initiatives, value stream activities, kaizen events and Quality Improvement efforts (potentially including BIC).Conducting Internal Audits as directed by QA Supervisor.Use micrometers, dial/digital calipers, scales, height gages, optical comparitors, hardness testers, colorimeters, and any other equipment necessary to ensure visual conformance, form fit, and function, etc. in addition to using electrical and computer testing processes (paint evaluation, anodizing, etc.) and other commercial chemical processes.Works from detailed drawings, specifications, other applicable standards (ASTM), verbal instructions, and EPR and other inventory management systems to perform job.Makes decisions as to whether or not parts are acceptable, can reject any job or process that is nonconforming based on findings, works with any department necessary to ensure the proper disposition of deviant material, and performs stock and plant purges for each rejection to ensure that all deviant material is captured.Maintains all equipment that is used in assigned work area, calibrates equipment as required by calibration procedure, and keeps assigned work area clean and orderly, including full application of 5S + Safe working practices.Performs all other duties outlined in specific standardize work, work instructions and/or procedures such as first piece inspections, product quality audits, engineering change orders, process capability studies as required. Initiates internal and external corrective or preventive action (CAPA) requests as required and may also be required to follow up on these requests as needed and to determine the effectiveness of actions takenPerforms all necessary reports and other paperwork as required with all phases of job, including but not limited to, DMR , PQA, cost of quality, etc. Show less

o Performed internal audits to ISO 13485:2003o Overseen department relations for Production flowo Support interaction between Engineering and Manufacturingo Support Supply & Demand on materials forecasting and sale order processingo Work with Engineering and Product management on new product development o Validate new products for recommendation of release, pro’s and con’s, and Product Manager’s education

o Back up foreman/department supervisor for all manufacturing areas and Quality o Ensured Manufacturing meets customer order requirements and dateso Assisted Plant Manager with daily operations

o Reviewed Direct to Quality Assurance (DQA) customer returns o Collected manufacturing data to perform defect trend analysis and supplier performance o Oversee incoming inspection of manufactured medical devices and PCB assemblies.o Created ISO Tier 3 and Tier 4 quality procedureso Participated in company ISO 13845:2003 audits and perform internal audits o Tracked internal and external product defects