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MERIT MEDICAL SYSTEMS INC. Quality Assurance Engineer I in SOUTH JORDAN, Utah

Requisition Number 500-17814 Job Title Quality Assurance Engineer I Working Hours US 800a-500p M-F Location South Jordan, UT Job Description Responsible for conducting internal quality system-compliance audits according to applicable standards and regulations. May perform routine quality engineering work for specific product lines under general supervision and guidelines when requested. Responsibilities include: ability to assess-evaluate failure investigations, disposition of nonconforming materials, risk analysis documentation, processes, quality inspection plans, performing data collection and trending for presentation of key metrics, validation-protocol data, and optimizing and improving quality systems and documentation. ESSENTIAL FUNCTIONS PERFORMED Ensures compliance to international regulations and standards through internal audits. Performs production-process and quality system internal audits to ensure they are documented, procedures are followed, and process controls are in compliance with referenced standards-regulations. Prepares audit plans, conduct audit meetings, coordinate audit process with process owners, perform internal audits, document audit evidence, and write audit reports. Follow up and assist with routine management of audit action requests and corrective-preventive actions. Performs routine engineering work requiring the application of standard techniques, procedures, and criteria in carrying out engineering tasks. Uses limited amounts of discretionary judgment in making decisions regarding engineering alternatives. Performs work of some higher technical level for training purposes, and work is screened to ensure correct application of scientific principles. Responsible for risk management documentation for assigned product line(s) or processes; and identifying and updating failure modes and related process-product improvements by facilitating teams and implementing required changes. Reviewing, approving and generating Engineering Change Notifications (ECNs) to update or generate: verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s). Evaluating and participating in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required. Reviewing nonconformance records (internal-external) to determine: disposition, root cause and need for corrective and preventive Ensuring containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.Identifying and implementing any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of: quality policy, quality objectives, audit results, analysis of data, etc. Evaluating the work environment, in which product is manufactured, is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls. May participate in design and development activities. Performs other related duties and tasks as required. SUMMARY OF MINIMUM QUALIFICATIONS * Education and-or experience equivalent to a Bachelors Degree in Quality Engineering or related field, or a Masters Degree. * Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member. * Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485:2003, ISO 13485:2016, Council Directive 93-42-EEC, SOR-98-282,... For full info follow application link. EQUAL OPPORTUNITY EMPLOYER M-F-D-V. Equal Opportunity Employer Minorities-Women-Protected Veterans-Disabled