Sr. Quality Assurance Engineer II

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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Quality Assurance Engineer

Details: Atkins has been providing infrastructure planning, engineering, construction, environmental consulting, urban planning, architecture, and program management services to public and private clients across the United States for more than 50 years. Globally, Atkins is the largest UK-based engineering and design consultancy and the world's 11th largest design firm with nearly 18,000 employees worldwide. We have the depth and breadth of expertise to respond to the most technically challenging and time-critical infrastructure projects and the urgent transition to a low-carbon economy. At Atkins, we offer our employees more than just a job; we offer an opportunity to shape the world for generations to come through innovative and sound design. As the official engineer of the 2012 London Olympics, few companies can rival the size and diversity of our projects. Whether it’s the concept for a new skyscraper, the upgrade of a rail network, the modeling of a flood defense system or the improvement of a management process, we plan, design and enable solutions. Atkins seeks an energetic, highly motivated, detail-oriented, self-starter to join our Atlanta office staff as a Quality Assurance Engineer. SUMMARY DESCRIPTION OF DUTIES: ? Understands the basic of elements of Request for Proposal (RFP) and Invitation for Bid (IFB) contracts as well as principles, practices, standards, and procedures of quality assurance. ? Communicates clearly and concisely, both orally and in writing. Prepares clear and concise reports, correspondence, and technical documents. Produces quality reports associated with work activities as well as audits. Verifies completion and quality of work, records findings, maintains and produces accurate logs, files and other documentation including photos. ? Monitors quality assurance aspects of contract performance in design, manufacturing, and installation activities. ? Monitors and evaluates quality assurance elements of assigned projects. Evaluates contractor/supplier compliance with contractual specification requirements. ? Evaluates effectiveness of contractor’s quality assurance program plan and recommends improvements. ? Researches and recommends acceptance of submitted materials and equipment. ? Reads and interprets plans, drawings, specifications, standards and procedures. ? Reviews documents, ensures contract compliance, the use of proper methods, and compatibility with other systems. ? Conducts and documents inspections. (i.e., Release for Shipment (RFS), Installation Verification (IV), and First Article/First Article Configuration (FAI/ FACI)). ? Attends and participates in projects meetings and stays abreast of quality requirements, issues/concerns, and scheduling. ? Leads and documents audits and surveys of contractor/supplier quality system. Approves and verifies implementation of necessary action plans to correct/improve and prevent quality deficiencies. ? Works independently in the absence of supervision. Knows principles of business writing and basic report preparation. Able to write properly constructed sentences, use punctuation, and correct grammar effectively. ? Understands and follows oral and written instructions. ? Assists in developing special quality assurance training content. ? Familiar with safe work practices and procedures. ? Establishes and maintains effective working relationships with others. ? Proficient on using current office equipment including copiers and computers, and supporting word processing and spreadsheet applications. ? Performs other duties as assigned. KNOWLEDGE/SKILLS/ABILITIES: ? Participates in the, implementation, and maintenance of quality assurance plans and programs. ? Creates standards of performance and inspections systems, establishes quality assurance testing models for analysis of raw materials, materials in process, and finished products. ? ? Performs quality system audits and implements necessary action plans to correct or improve quality deficiencies. ? Produces quality reports associated with work activities. Verifies completion and evauluates quality of work. Records findings. Produces and maintains accurate logs. Recommends corrective and preventive action. ? Facilitates quality awareness with internal customers by providing information and education of methods for identifying and improving quality. ? Knowledge of computer software applications. ? Excellent analytical and problem solving skills. ? Highly responsive to changing demands. ? Forward thinking ability. Atkins offers its employees a robust rewards package which includes: a competitive salary; a broad benefits package including medical/RX, dental, vision, life, disability, legal, hospitalization and other valuable voluntary options; generous time-off programs; flexible work schedules; 401(k) with employer match; professional and career development opportunities through our corporate university, as well as a highly-regarded tuition reimbursement program; and an unmatched culture focused on client-service, quality, and tireless pursuit of excellence in all we do. Atkins is an equal opportunity, drug-free employer committed to diversity in the workplace.

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Quality Assurance, Quality Control Professionals

Details: EngineersSafetyLogisticsIf you are a Dallas area professional and have Engineeriing, Quality Control or Logistics experience then allow us to assist you.

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