ResponsibilitiesInvestigate complaints daily: responsible for quality compliance duties relating to customer complaints, including but not limited to preliminary classification of complaints, customer and product follow ups, maintaining investigation records and all other supporting documentations, and assign additional actions as necessary to close complaint.Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics.Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; elevate complaints thatrequire additional review for regulatory reporting.Verifies that the correct number of complaints have been opened to address all of the issues identified in the complaint description.If required, generates additional complaint records to document all of the issues listed in the complaint description.Requests information from the customer related to complaint, including the return of product(s) that are part of a system (e.G., sensor‐cable‐monitor).




Reviews QPM trends related to complaints for potential trend.Ensures applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.Evaluates each complaint to determine if an investigation is required; where investigation is needed, determines timelines with Failure Analysis Lab to ensure timely evaluation of product complaints and completion of reports.Reviews complaint investigation reports to ensure investigations are thorough, adequate, and in accordance with procedures.Executes duties in compliance with established company policies.Develops a thorough understanding of the complaint database.Performs other duties or special projects as assigned.QualificationsAdvanced English.VISA B1.Minimum of 2 years' experience as a Quality Compliance Engineer.Comprehensive knowledge of Quality Systems, quality records, and FDA regulations (21 CFR Part 820 and Part 803) and ISO ***** standard.Experience in handling customer complaints.Ability to analyze situations thoroughly, identify potential problems, find and implement effective solutions.Hands‐on experience implementing and using statistical methods throughout various aspects of product realization, including but not limited to the use of Minitab, PFMEA, DOE and Gage R&R; methodologies.Developing quality control systems.
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📌 Quality Compliance Specialist (Mexicali)
🏢 Masimo
📍 Mexicali