Merit Medical Systems, Inc. is dedicated to creating innovative medical devices that enhance lives. They are seeking a Quality Assurance Engineer I to perform routine quality engineering work, including failure investigation, risk analysis, and quality inspection planning.
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 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 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 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
Qualification
Required
Education and/or experience equivalent to a Bachelors Degree in Quality Engineering or related field, or a Masters 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
Preferred
Medical device experience or equivalent experience in a regulated industry
Experience with SmartCAPA, Oracle and Crystal Reports
Experience handling deviations, investigations and CAPAs
Benefits
Medical/Dental & Other Insurances (eligible the first of month after 30 days)
