Merit Medical Systems, Inc. · 1 day ago
Senior Quality Assurance Engineer I
South Jordan, UT
Full-time
Onsite
Senior Level
6+ years expMerit Medical Systems, Inc. is dedicated to creating innovative medical devices that improve lives. They are seeking a Senior Quality Assurance Engineer I who will provide quality engineering support for products and processes, ensuring compliance with quality requirements and optimizing quality systems.
Health CareManufacturing
Responsibilities
Provides extensive and diversified quality engineering support for products and processes while completing projects in broad areas of assignment
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
Contributes techniques which are of material significance to solve specific problems and drive continuous improvement
Keeps abreast of new scientific methods, standards, regulations, and developments affecting the organization for the purpose of recommending changes to processes, systems or designs warranted by such developments
May plan, organize, mentor, and supervise the work of engineers or technicians on various engineering projects and quality system compliance issues
Responsible for coordinating risk analysis/management activities. This may include leading risk management analysis meetings, documenting results, following up to ensure risk mitigation and facilitating improvements
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, risk management, etc
Evaluates the work environment in which product is manufactured, and ensures it is adequately controlled and monitored, with sufficient personnel and safety production controls
May participate in design and development activities
May support Internal Audit and supplier audit activities, performing audits, writing audit reports, and following up on effectiveness of corrective/preventative actions
Performs other related duties and tasks as required
Strong statistical analysis / evaluation
Qualification
Required
Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with six years of quality engineering experience (to include experience in the development and implementation of effective quality systems)
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
Knowledge of applicable regulatory agency regulations
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
Preferred
Medical device experience or equivalent experience in a regulated industry
Experience handling deviations, investigations and CAPAs
Experience with MasterControl, SmartCAPA, Oracle and Crystal
Statistical Analysis (Green Belt / Black Belt)
Benefits
Medical/Dental & Other Insurances (eligible the first of month after 30 days)
Low Cost Onsite Medical Clinic
Two (2) Onsite Cafeterias
Employee Garden | Gardening Classes
3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
401K | Health Savings Account
Company
Merit Medical Systems, Inc.
As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care.
5001-10000 employees
H1B Sponsorship
Merit Medical Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2022 (4)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.07BKey Investors
Starboard Value
2023-06-07Post Ipo Debt· $850M
2020-01-14Post Ipo Equity
2018-07-31Post Ipo Equity· $217M
Leadership Team
Martha Aronson
President and Chief Executive Officer
N
Neil Peterson
Chief Operating Officer
Recent News
BioWorld Financial Watch
2026-01-11
Columbia West
2025-12-13
Company data provided by crunchbase