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CONMED Corporation Senior Quality Engineer in Denver, Colorado

The SENIOR QUALITY ENGINEER will provide Quality Engineering support to allfunctions for the design, procurement, assembly, test,manufacturing, validation, and distribution of medical devices,processes, and quality systems to ensure that all CONMED products are infull compliance with customer and regulatory requirements. DUTIES AND RESPONSIBILITIES: * Develop, Implement, and maintain quality system processes andprocedures to ensure compliance to all domestic and international standards orrequirements. (EN ISO 13485/CMDCAS/MDD .and. FDA QSR) * Keep current on all applicable best practices and statutory regulationsgoverning the design, procurement, manufacture, marketing, anddistribution of medical devices. * Demonstrate leadership and initiative to plan and perform engineeringassignments that support company goals and objectives. * Develop and implement quality programs, including tracking,analyzing, reporting, problem solving. Acquire and analyze data usingappropriate standard quantitative methods across a spectrum of businessenvironments to facilitate process analysis and improvements. * Support development through capability assessment, analyzingperformance data, facilitating problem-solving activities, developingquality tools and techniques. Driving VA/VE efforts, solving process anddesign problems. * Review and approve engineering designs/changes for adequatequality, reliability, maintainability, and risk management,modeling, systems design, assessment tools, reporting and manufacturability. * Investigates process and product issues identified through complaintsand trend analysis of other conformance data. Works with other functionalgroups to resolve difficult quality problems on products, processes, ormaterials used in manufacturing operations. Direct and facilitateinvestigations and resolution of validation failures, process deviations,abnormal results, complaints and quality inquiries and other qualityperformance indicators. * Plans, controls, and assures product and process quality whichinclude planning processes, material control, acceptance sampling, andmeasurement systems. Assists in the development and implementation of productand process quality plans and inspection and testing strategies. Providessupport for the development and implementation of process validations andequipment qualifications. * Provides input on test methods and protocols to ensure material andproduct verification activity is adequate to assure the safety and efficacy ofthe device and ensure the completion of necessary design verification andvalidation activity including biocompatibility, sterilization validations,and product shelf life testing on new devices for product development teams. QUALIFICATIONS: * 5-10 years experience in medical, mechanical or electricalproduction, test, and/or inspection is required with a high level ofanalytical and problem solving skills. * Bachelor's Engineering degree in Electrical and/or Software,Industrial, Mechanical, or Chemical. * Mastery of quality philosophies, principles, systems, methods,tools, standards, organizational and team dynamics, customerexpectations and satisfaction, supplier relations and performance,leadership, training and improvement systems. * Knowledge of management and planning tools, quality tools,preventive and corrective actions, DMAIC, statistical principles and howto overcome barriers to quality improvements. Expected Travel 0-20% This position is not eligible for employer-visa sponsorship. BENEFITS:CONMED offers * Competitive compensation * Excellent healthcare including medical, dental, vision andprescription coverage * Short .and. long term disability plus life insurance -- cost paid fullyby CONMED * Retirement Savings Plan (401K) -- company match dollar for dollarup to 7% Employee stock purchase plan -- allows stock purchases atdiscounted price.Tuition assistance for undergraduate and gradua