GE Betz Inc. Manufacturing Quality Engineer-Endotoxin in Boulder, Colorado

Job Title: Manufacturing Quality Engineer-EndotoxinLocation of Position: 6060 Spine Road, Boulder 80301-3687 USAPosting Number: req1040Description:The Manufacturing Quality Engineer will be the leader and owner of the qualityprocess for the endotoxin product line. This position will provide qualityplanning, control, and improvement support for product developmentteams, manufacturing engineering, supply management, and manufacturingand/or distribution organizations to assure product quality meets thecustomers' expectations. This position will also be working with teams andsuppliers from around the globe to ensure standard and consistentmanufacturing quality requirements and standards are met.Essential Functions/Responsibilities* Development of quality processes aligned with regulatory requirements* Build sustainable manufacturing quality processes that meet all stringentregulatory and company requirements* Create critical manufacturing operating procedures and approve all supplierchanges* Drive pro-active quality using value stream mapping and process failure modeeffects analysis (PFMEA)* Drive process monitoring and control at critical suppliers* Execute validations, reliability test plans, and product stability studies* Conduct Design of Experiments for critical product parameters* Perform root cause failure analysis and lead the execution of root causecorrective actions.* Participate on quality improvement teams as the quality representative,ensuring quality activities and plans are formulated and followed* Engage in applying/leading quality tools* Encourage ea rly interaction of both customer and supplier input to teamactivities* Participate in design process and assembly reviews, print reviews anddesign reviews of new products* Monitor and facilitate quality activities for parts approval, verifysupplier manufacturing processes (control plans, assembly instructions)and confirm process capability* Use quality tools and practices to establish approval criteria to ensure theidentification of quality failure concerns for both internal and externalmanufactured parts and assemblies* Engage in applying/leading quality tools on customer support process,continuous improvement, and/or value improvement teams* Execute quality control plan where implemented* Investigate product quality problems, determine root cause for qualityproblems, gather and analyze data and implement corrective action to reduceor eliminate non-value waste resulting from non-conformances, scrap or reclaim* Assist in iden tifying, communicating and resolving supplier qualityproblems* Engage in supplier quality plan formulation* Conduct audits of new and existing suppliers to determine manufacturingcapability and adherence to accepted quality practices* Identify and drive preventive actions* Facilitate and write quality procedures for maintaining/updating themanufacturing quality system and supports quality system audits, reviewsresult with audit team, and participates in management review meetingsProvide training and/or supervision to co-workers, inspectors,technicians and auditors on quality procedures and tools to monitor criticalprocesses to assure consistent control and/or to implement cost-saving ideasto improve our products to meet customer expectationsQualifications/RequirementsBachelor's Degree in Chemistry, Chemical Engineering, Bio-ChemicalEngineering or re lated degree/programSkills and Abilities* Manufacturing knowledge/experience* Process improvement methodology and experience* Testing knowledge/experience for endotoxin* Quality Control knowledge* Sampling theory* Collecting and summarizing large amounts of data* Continuous improvement experience* Statistical Process Control (SPC)* Failure analysis and troubleshooting of complex products* Root cause analysis and corrective action* Excellent oral and written communication skills to communicate complex data* Experience in International Quality Standards, particularly ISO 9001:20015* Awareness of cGMP s