Utah Engineering Jobs

Mobile utah department of workforce services Logo

Job Information

MOOG INC Risk Management Quality Engineer in SALT LAKE CITY, Utah

At Moog:* We solve our customers' most difficulttechnical challenges* We value trust, respect, integrity and cooperation in everything we do* Performance really matters - for our people, customers and shareholdersIf this sounds like the kind of organization you want to be a part of, continuereading...We are the Medical Devices Group of Moog - aglobal organization that operates in 23 countries. Our expertise lies inapplying advanced technologies to the precision control of motion and fluids.Underlying this expertise is a set of values and beliefs that guides ouractions: we pride ourselves on solving challenging problems that make adifference; we strive to be flexible to our customers' unique needs; we do whatwe say we'll do; and we believe close working relationships provide betterresults.Moog Medical Devices Group designs, manufactures, and distributesindustry-leading enteral feeding and infusion pumps. Through investment inresearch and development and relying on our vast expertise, we design anddevelop advanced infusion systems that improve medication safety, optimizeapplication performance and reduce medical expenses.The Risk Management QualityEngineer is responsible for the complete risk management process usedthroughout the lifecycle of the device including design, development, qualitysystems, and post market efforts. The incumbent shall coordinate efforts amongdifferent functions and franchises to effectively manage risk documentsincluding, but not limited to, risk analysis and assessment, FMEAs, controls,and risk-benefit analysis. Additionally, the incumbent will provide QualityEngineering and Quality Assurance with technical expertise and functionalsupport to execute the processes in compliance with FDA Quality SystemRegulations, other FDA regulations, ISO, MDR and other internationalregulations.ESSENTIAL DUTIES ANDRESPONSIBILITIES* Coordinates with other functions to develop, evaluate, reviewand approve risk management files for each product and-or family.* Creates, reviews and approves Quality System documents, asrequired.* Performs complaint review and analysis to determine appropriate risk and occurrence of product failures, as needed.* Analyzes product and process non-conformances, CAPAs, field actions, design or manufacturing process changes, services reports, customer feedback and technical or regulatory standards changes for impact to the risk files for product families.* Conducts required risk management file reviews per schedule to support Post Market Surveillance activities.* Maintains the integrity of all quality documentation.* Reviews and updates risk documents on a predefined basis to meet regulatory and product requirements* Meets performance objectives as defined annually in support of monthly and quarterly metrics and business strategies.* Other duties may be assigned as appropriate.EDUCATION - EXPERIENCE* Experience: Minimum of three (3) years relevant experience performing risk assessments - risk evaluations within a device - diagnostic, pharmaceutical, or biotech environment.* Education: Bachelor's degree in Engineering, Life Sciences or related discipline (Engineering, Chemical Engineering, Chemistry, Biology, etc.)* Familiarity with current industry practices and guidelines including those required - outlined by the FDA, ISO, EU, etc.QUALIFICATIONS* Strong listening, assessment, questioning, analytical, and problem-solving skills.* Comprehensive knowledge of quality systems regulations and risk management.* Ability to work independently with general direction from senior management.* Ability... For full info follow application link.EOE-AAMinority-SexualOrientation-GenderIdentity-Female-Disability-Veteran #Manufacturing