Details: SENIOR QUALITY ASSURANCE ENGINEER II (500-4103)SOUTH JORDAN, UTAHSUMMARY OF DUTIESProvides quality engineering support for optimization, improving, and implementation of software quality systems including generating validation/protocol data, and training.Must have quality engineering experience in failure investigation, oversight/determination of disposition of nonconforming materials, conducting and updating risk analysis documentation and processes, defining/refining quality inspection plans, performing data collection and trending for presentation of key metrics, identifying and addressing supplier quality issues, reviewing and generating validation/protocol data documentation.ESSENTIAL FUNCTIONS PERFORMED•Ensures that new systems are appropriately tested and documented prior to implementation.•Ensures that employees are adequately trained prior to any use of new or existing systems.•Ensure that training on quality systems is adequately documented.•Identifies opportunities to improve quality systems and processes.•Provide project management when needed for implementation of new quality systems or improvement of existing quality systems.ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS•Lifting -- Not to exceed 50 lbs. ? local practice may apply.•Writing•Sitting•Standing•Bending•Vision•Color perception•Depth perception•Reading•Field of vision/peripheral•Fine motor skills•Noise•Chemical vaporsSUMMARY OF MINIMUM QUALIFICATIONS•Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with five years quality engineering experience.•Medical device experience or equivalent experience in a regulated industry preferred.•Experience handling deviations, investigations and CAPAs preferred.•Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, 21 CFR 11, Annex 11 and other medical device related standards.•Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs. Experience with MasterControl, SmartCAPA, Oracle, Crystal Reports and HTML is highly desirable.COMPETENCIES•Engineering research•Engineering problem solving•Inventions/new designs/techniques•Work/project supervision•Special projects/ECN's/ prototype creation.•NCMR causes/corrective actions/dispositionsCOMMENTSInfectious Control Risk Category II:The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.TO APPLY External candidates: Please submit an application on our website www.merit.com/careers to be considered. Click browse current openings to see the several pages of openings. Click the page numbers to see other openings.Internal candidates: Please log in to the employee services part of the Merit Metro and go under the "Merit Job Openings" button to view and apply to the opening. This can only be done while at work, not from home.Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice. To see what it is like to work at Merit take a look at our new recruiting video on YouTube at www.youtube.com/meritmedical to see the video titled "Great people, Great products, Great Company". Excellent compensation and benefits packages will be offered to the right candidate.COMPANY HISTORYMerit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos and Kent W. Stanger, Chief Financial Officer. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies. Merit also develops and markets embolotherapeutic products for the treatment of uterine fibroids, hypervascularized tumors, and arteriovenous malformations. Embolotherapy procedures are primarily performed by interventional radiologists and use bioengineered microspheres to create targeted vascular occlusion and drug delivery. The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to U.S. hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a direct sales force in Europe, and distributors for the remainder of the world.MERIT MEDICAL SYSTEMS, INC.1600 Merit Parkway(9800 South Redwood Road)South Jordan, UTwww.merit.comEQUAL OPPORTUNITY EMPLOYER M/F/D/V
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