ESSENTIAL FUNCTIONS PERFORMED1.
Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.2.
Works independently on standard projects while assistance is furnished on unusual problems.3.
Receives instructions on specific assignment objectives, complex features and possible solutions.4.
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.5.
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).6.
Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.7.
Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.8.
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.9.
Evaluates the work environment, in which product is manufactured, is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDSLifting – Not to exceed 50 lbs.




– local practice may apply.WritingSittingStandingBendingVisionColor perceptionDepth perceptionReadingField of vision/peripheralFine motor skillsNoiseChemical vaporsSUMMARY OF MINIMUM QUALIFICATIONSEducation and/or experience equivalent to a Bachelor's Degree in Engineering or related field with three years quality engineering experience in medical devices.Prior medical industry experienceAdvanced English levelStrong 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 *****, ISO*****, 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 QUALIFICATIONSMedical device experience or equivalent experience in a regulated industry.Experience handling non-conformances, deviations, investigations and CAPAs.Experience in revieweing and approving validations for molded products.COMPETENCIESEngineering techniques/evaluation/selection/applicationEngineering variable analysisPlans/surveys/structures/equipmentSupervisory assistanceSpecial projects/ECN's/prototype creationNC causes/corrective actions/dispositionsCOMMENTSInfectious Control Risk Category II:The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs.Risk category II states employment and procedures that may require exposure.
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📌 Quality Assurance Engineer Ii (Molding) (Tijuana)
🏢 Merit Medical
📍 Tijuana