Quality Assurance Engineer II (Molding)Applyremote type: Onsitelocations: Tijuana, Mexicotime type: Full timeposted on: Posted Yesterdayjob requisition id: JR116663Work Shift:DAYWork Schedule:Why Merit?At Merit Medical, our mission is to create innovative medical devices that improve lives. Works independently on standard projects while assistance is furnished on unusual problems. Reviews, approves and generates Engineering Change Notifications (ECNs) to update or generate: mold verification, mold validation, monitoring and inspection methods, procedures, and test protocols; specific to mold product line(s) and processes and production control(s). 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. 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 three years quality engineering experience in medical devices. • Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards. • 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 a

📌 Quality Assurance Systems Engineer (Tijuana)
🏢 Merit Medical Systems
📍 Tijuana