- SUMMARY OF DUTIES
Performs routine quality engineering work for specific product lines under general supervision and guidelines. Responsibilities include: failure investigation, oversight/determination of the disposition of nonconforming materials, conducting and updating risk analysis documentation and processes, defining/refining quality inspection plans, performing data collection and trending for the presentation of key metrics, identifying and addressing supplier quality issues, reviewing and generating validation/protocol data, and optimizing and improving quality systems and documentation.
"Must be vaccinated against COVID-19, unless otherwise prohibited by applicable law. You must have received your first dose of COVID-19 vaccination by your first day of employment, and for two-dose COVID-19 vaccines, you must receive your second dose within thirty days of your first day of employment. Merit will consider exemption requests in accordance with federal, state, and local laws."
ESSENTIAL FUNCTIONS PERFORMED
- 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 the 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 actions.
- Ensuring containment (identification, segregation, and reconciliation) of the 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 the 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’s Degree in Quality Engineering or related field, or a Masters’s 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, ISO14791, and other medical device-related standards.
- Proven ability to work effectively in a team environment through conflict resolution and negotiations.
- Working knowledge of statistical methodologies, quality control, and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc.
- Demonstrated computer skills preferably spreadsheets, word processing, database, and other applicable software programs.
- Medical device experience or equivalent experience in a regulated industry.
- Experience handling deviations, investigations, and CAPAs.
- Experience with SmartCAPA, Oracle, and Crystal Reports.
- Standard engineering techniques/procedures/criteria
- Special projects/ECN’s
- NCMR causes/corrective actions/dispositions
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 #LI-MM1 #IND2
Location/Region: South Jordan, UT