Quality Assurance Auditor - 2Nd Shift

Merit Medical Systems, Inc. Pearland , TX 77584

Posted 3 weeks ago

SUMMARY OF DUTIES

This position is responsible for auditing medical products to ensure that they have been manufactured according Merit's policies, procedures, specifications and standards.

ESSENTIAL FUNCTIONS PERFORMED

  • Generation and distribution of NCMR's for specific area -- QAP's and MPS's.

  • Audits the production process to confirm that Device History Records are completed according to Device Master Record/QSR/GMP regulations.

  • Audits finished products to ensure that it conforms with Device History Records/applicable specification and procedures.

  • Completes final inspection paperwork.

  • Performs work order reviews for ECN's, EPWO's, NCMR's, etc.

  • Documents inspections/rejections on inspection paperwork.

  • Segregates product when discrepancies are noted.

  • Initiates and ensures closure of NCMR's.

  • Accountable for the disposition agreement/verification of NCMR's.

  • Initiates, identifies (labels) and ensures closure of NCMR's. Enters information into NCMR database.

  • Operates basic testing equipment in verifying that final product meet specification.

  • Performs other related quality auditing tasks, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

  • Lifting -- up to 50 lbs

  • Writing

  • Sitting

  • Standing

  • Bending

  • Vision

  • Color perception

  • Depth perception

  • Reading

  • Field of vision/peripheral

  • Fine motor skills

  • Noise

  • Chemical vapors

  • Soldering fumes

SUMMARY OF MINIMUM QUALIFICATIONS

  • Education and experience equivalent to a High School Diploma with a minimum of one year of related experience.

  • Demonstrated knowledge of business mathematics.

  • Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs

  • Excellent attention to detail and the ability to meet deadlines in a timely manner.

  • Ability to learn to operate basic test equipment.

  • Communication and interpersonal skills and the ability to work well with others.

COMPETENCIES

  • Production process auditing for specific and general area -- PPS's, QAP's, MPS's, and GPS's

  • Finished product auditing

  • Basic test equipment operation

  • Final inspection paperwork

  • Work order reviews

  • Product final inspection

  • Generation and distribution of NCMR's

  • Specification training

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". Merit currently has the above opening located in South Jordan, Utah. Excellent compensation and benefits packages will be offered to the right candidate.

COMPANY HISTORY 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.

www.merit.com/careers

EQUAL OPPORTUNITY EMPLOYER M/F/D/V

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Quality Assurance Auditor - 2Nd Shift

Merit Medical Systems, Inc.