Summary

Merit Medical Systems, Inc. is a leading global manufacturer and distributor of disposable medical devices used in diagnostic and therapeutic procedures, particularly in interventional cardiology, radiology, oncology, and endoscopy. Founded in 1987 by Fred P. Lampropoulos and headquartered in South Jordan, Utah, the company develops innovative products that improve patient outcomes while reducing healthcare costs. Merit Medical's extensive product portfolio includes angiography products, embolization devices, drainage catheters, biopsy needles, and various other minimally invasive medical devices. The company operates manufacturing facilities worldwide and maintains a strong commitment to quality, innovation, and customer service. With a focus on developing solutions for interventional specialists, Merit Medical has established itself as a trusted partner in the medical device industry, serving healthcare providers across more than 100 countries through its direct sales force and distribution network.

Job description

Essential Functions Performed

Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
Works independently on standard projects while assistance is furnished on unusual problems.
Receives instructions on specific assignment objectives, complex features and possible solutions.
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.
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).
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, 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 Bachelor's Degree in Engineering or related field with three years quality engineering experience
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.

Preferred Qualifications

Medical device experience or equivalent experience in a regulated industry.
Experience with SmartCAPA, Oracle and Crystal Reports.
Experience handling deviations, investigations and CAPAs.

Requirements

Bachelor's Degree in Engineering or related field
Three years quality engineering experience
Strong interpersonal, organizational, and verbal and written communication skills
Ability to work effectively as a team member
Working knowledge of 21 CFR 820 (Quality Systems Medical Devices)
Working knowledge of ISO 13485
Working knowledge of ISO14791
Working knowledge of 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
Working knowledge of applied statistics, lean manufacturing, Six Sigma
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs

Benefits

Medical, Dental & Vision Insurance
Onsite Medical Clinic
Onsite Cafeterias
Employee Garden
Gardening Classes
3 Weeks Vacation
1 Week Sick Time
Paid Holidays
401(k)
Health Savings Account

Company overview

Merit Medical Systems, Inc. is a leading global manufacturer and distributor of disposable medical devices used in diagnostic and therapeutic procedures, particularly in interventional cardiology, radiology, oncology, and endoscopy. Founded in 1987 by Fred P. Lampropoulos and headquartered in South Jordan, Utah, the company develops innovative products that improve patient outcomes while reducing healthcare costs. Merit Medical's extensive product portfolio includes angiography products, embolization devices, drainage catheters, biopsy needles, and various other minimally invasive medical devices. The company operates manufacturing facilities worldwide and maintains a strong commitment to quality, innovation, and customer service. With a focus on developing solutions for interventional specialists, Merit Medical has established itself as a trusted partner in the medical device industry, serving healthcare providers across more than 100 countries through its direct sales force and distribution network.