Merit Medical Systems, Inc.
About the job
Our Quality Assurance Technicians provide support for customer inquiries and requests regarding quality compliance. * Our Quality Assurance Technicians work at a high level of aptitude interacting with internal cross-functional groups as well as external customers. * Performs non-routine quality technical assignments of substantial variety and complexity, under general supervision and guidelines.
ESSENTIAL FUNCTIONS PERFORMED
* Answers and resolves customer (e.g., external and internal) inquiries regarding systems and products with Merit Medical’s focus to quality compliance. * Prepares written correspondence to address customer inquiries and/or concerns. * Assists Quality Engineering with the identification and control of Quality Compliance risks. * Identifies uncovered customer and/or process needs and assures needs and problems are properly communicated. * Provides information to staff regarding customer compliance issues. * Develops reports and compiles information for customers, departments and company management. * Conducts research, follow-up and tracking regarding customer recommendations and concerns. * Maintains up-to-date knowledge of company products. * Assists in the development or edit of new/revised procedures, forms, specifications. * Updates/develops new systems and procedures to streamline business practices. * Proactively and continuously improves internal systems and processes with a quality mindset.
ADDITIONAL ESSENTIAL FUNCTIONS PERFORMED
*Generates Engineering Change Notifications (ECNs) to update Quality System documentation such as: procedures, forms, drawings, BOM/routers, workmanship standards, test methods, and/or inspection criteria. * Initiates internal/external nonconformances and responsible for assuring all phases are complete. * Evaluates internal/external nonconforming product in determining appropriate root cause, disposition and corrective action. * Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed to prevent unintended use. May include performing inventory management transactions. * Evaluates product placed in Quarantine/on hold to assure that it’s dispositioned in a timely manner. Will determine if product/components can be transacted into/out of Quarantine based on supporting documentation provided by Engineering, and perform the transactions as applicable. * Identifies training needs, develops training plans and performs Quality Compliance training of technicians, Quality auditors or Production employees. * Assists Quality Engineering with the identification and control or Quality Compliance risks. * Evaluates the manufacturing work environment to ensure it is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls. * Collects and submit information for material characterization testing such as MEM/IR. * Researches customer inquiries into Merit’s compliance to applicable standards. Generates responses to various customer inquiries. * May assist with the supervision of technicians to include assigning work, ensuring proper completion of assignments and processes, and assisting with performance appraisals. * May participate in design and development activities. * Performs other related duties and tasks as required.
SUMMARY OF MINIMUM QUALIFICATIONS
* Education equivalent to a High School Diploma with 7 years previous work related experience. College education preferred. * Medical device industry knowledge strongly preferred. * Working knowledge of quality compliance system requirements and medical device regulations. * Understanding of regulatory initiatives preferred (i.e. REACH, RoHS, BPA, California Prop 65, Conflict Minerals, Latex, DEHP, etc. * Excellent interpersonal, written and verbal communication skills and the ability to resolve customer requests efficiently and effectively. * Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs (e.g., Oracle). * Good organizational skills and the ability to work under strict time constraints to meet the demands of customers. * Attention to detail. * Ability to manage multiple projects and tasks simultaneously and to prioritize work, goals and tasks per corporate objectives. * Ability to work independently and with cross-functional teams.
* Working knowledge of Excel * ECN generation/review/approval * Training skills.
Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. 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, UT www.merit.com EQUAL OPPORTUNITY EMPLOYER M/F/D/V