R & D Senior Quality Engineer I Job in South Jordan 84095, Utah Us
R D Senior Quality Engineer I
Position Description:
South Jordan, UT
SUMMARY OF DUTIES
Provides intensive and diversified quality engineering support for specific product lines while completing projects in broad areas of assignment. Basic responsibilities include: Quality/ technical support and mentoring and training of quality assurance employees, 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, and optimizing and improving quality systems and documentation.
ESSENTIAL FUNCTIONS PERFORMED
• Conducts complete and conceptually related studies to approach technical problems, whereas the problems are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques.
• Performs technical work where available guides and precedents contain critical gaps, are only partially related to the problem, or may be largely lacking due to the novel character of the project.
• Generally contributes techniques which are of material significance in the solution of specific problems.
• As a staff technical specialist, keeps abreast of new scientific methods and developments affecting the organization for the purpose of recommending changes in emphasis of programs or new design programs warranted by such developments.
• May plan, organize, and supervise the work of engineers or technicians and may be assisted on various engineering projects.
• Responsible for risk management documentation for assigned product line(s) or processes; and identifies and updates failure modes and related process/product improvements by facilitating teams and implementing required changes.
• Reviews, approves and generates 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).
• Mentors and evaluates competency of Quality Auditors, Quality Engineers, and technicians, by providing training or other actions required to satisfy quality objectives.
• Evaluates and participates in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required.
• Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
• Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
• Identifies and implements 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.
• Evaluates the work environment in which product is manufactured, and ensures it 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.
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 vapors
SUMMARY OF MINIMUM QUALIFICATIONS
• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with six years quality engineering experience
• Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member.
• 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, 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. Experience with MasterControl, SmartCAPA, Oracle and Crystal Reports is highly desirable.
COMPETENCIES
• Engineering problem solving/decision making
• Technician supervision
• Special projects/ECN's/prototype creation
• NCMR causes/corrective actions/dispositions
COMMENTS
Infectious 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
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.
External candidates: Please submit an application on our website www.merit.com/careers then click browse current openings.
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 following opening at its Corporate headquarters 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 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. 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.
1600 West Merit Parkway
(9800 South Redwood Road)
SOUTH JORDAN, UT 84095
www.merit.com
EQUAL OPPORTUNITY EMPLOYER M/F/D/V
To Apply, click here: Merit Medical Systems, Inc.
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