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TOLMAR Inc. Sr. Quality Engineer in Fort Collins, Colorado

The Sr. Quality Engineer will have the opportunity to provide engineeringleadership on a daily basis by developing, establishing and maintainingquality engineering methodologies, systems, and practices that meetbest-in-class industry standards. Among other tasks, this position willsupport non-conforming events and product failures to drive product/processimprovements with the objective of compliance safety and high customersatisfaction, and serve as a multi-functional team leader for qualityimprovement teams assuring commitments and objectives are achieved with positivEssential Duties and Responsibilities Ensure Risk Management is effective utilizing feedback fromvalidation, post market surveillance, manufacturing indicators, CAPAs, etc. Develop, implement and monitor quality metrics through our qualitymanagement review and communicate status and progress. Develop systems for monitoring manufacturing quality. Recommend andassist, as necessary, in the implementation of corrective/preventative actions. Lead problem-solving teams through root cause investigations and failureanalysis to implementation using various statistical techniques and qualitytools. Support data analysis for the APR program. Determine and recommend sampling plans, equipment requirements,measurement techniques and training requirements that will ensure specificquality levels. Proactively investigate, identify and implement best-in-class QualityEngineering practices, inspection and testing techniques. Support the new product development process using Quality by Design(QbD) principles, to assist with product specification development andyield calculations. Participate in and provide QbD guidance for project development teams. Facilitate and review risk assessment activities as needed. Support the development process in determining product qualityacceptance, defect classification and defining test methodologies. Define, identify and apply product and process control methods such asdeveloping control plans and identifying critical control points forsampling/inspection. Develop data reports, and track and trend data in support ofestablishing product performance. Participate in decision-making process regarding product/processquality issues. Interact with investigators/ auditors during regulatory inspectionsand marketing partner audits. Perform various other duties as assigned.Knowledge, Skills and Abilities Proficient knowledge with MS Office and statistical software packagesrequired (e.g minitab, SAS). Familiarity with Risk Management for medical devices and under ICHguidance. Proficient knowledge of Q8, Q9 and Q10 FDA Guidance. Knowledge of pharmaceutical development process and applicable tools. Knowledge of CAPA system and investigational tools. Excellent verbal and written communication skills demonstrated throughinteractions internally and externally. Excellent technical writing capabilities. Effective organization and project management skills. Effective troubleshooting and problem solving skills. Ability to work both independently and in conjunction with a team. Ability to develop working relationships with both internal and externalcustomers. SME in statistics with strong experience in Design of Experiment(DoE), design and modeling for RandD combined with formulationdevelopment support experience from a QE perspective. Ability to develop, lead and teach QbD tools and principles. Ability to lead risk analysis and risk management activities. Experience with FMEA processes. Stage 1 and stage 2 experience. Hands on knowledge of sampling plans and optimization. Ability to lead other engineers in statistical processes and analyses.Core Values The Senior Quality Engineer is expected to operate within the frameworkof Tolmar s Core Values:o Consistently operate with the highest standards of ethics and compliance.o Take ownership of your actions, success and setbacks.o Respect each other and understand that honest collaboration i

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