Merit Medical Systems, Inc. · 3 months ago
CAPA & Internal Audit Engineer II
South Jordan, UT
Full-time
Onsite
Mid Level
3+ years expMerit Medical Systems, Inc. is dedicated to creating innovative medical devices that improve lives. The CAPA & Internal Audit Engineer II is responsible for managing CAPA-related documentation, conducting internal audits, and ensuring compliance with quality management systems.
Health CareManufacturing
Responsibilities
Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner
Evaluates and ensures the timely completion of CAPA system activities throughout the lifecycle of the CAPA
Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance
Supports the attainment of CAPA goals and objectives, prepares metrics for Management Review
Coordinates CAPA Board Management reviews
Conduct internal audits and facilitate the Internal audit program
Lead and Perform on-site quality management system (QMS) internal audits to ensure compliance with internal and regulatory requirements
Preparation and Support of third party audits (Supplier, FDA, EU Notified bodies) in the front and, back room
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
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)
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
Performs other related duties and tasks as required
Qualification
Required
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
Medical device experience or equivalent experience in a regulated industry
Experience with Master Control, Oracle and DOMO
Experience handling Internal Audits Issues and CAPAs
Certified Internal Auditor or Lead Auditor for ISO13485
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
N
Neil Peterson
Chief Operating Officer
R
Robert D. Poser
Vice President, Technology
Recent News
BioWorld Financial Watch
2026-01-11
Columbia West
2025-12-13
Company data provided by crunchbase