Sr. Customer Quality Engineer

Masimo; Mexicali; Presencial; MXN 360.000 - 520.000; Jornada completa

Descripción de la vacante

Masimo Mexico seeks a Quality Compliance Engineer to investigate complaints daily, classify issues, and maintain complete records for timely closure in line with company procedures.

The role requires knowledge of FDA 21 CFR Part 820/803, ISO 13485, and global medical device standards; hands-on use of Minitab, PFMEA, DOE and Gage R&R to drive improvements and ensure compliance.

Formación

• Advanced knowledge of quality systems and regulatory requirements.
• Minimum 3 years' experience as a Quality Compliance Engineer.
• Experience handling customer complaints and defect investigations.

Responsabilidades

• Investigate complaints and classify per procedures.
• Coordinate with Failure Analysis Lab for timely evaluation.
• Maintain complaint records and related documentation.
• Ensure compliance with FDA and ISO regulations during investigations.
• Generate additional records to document all issues identified.

Conocimientos

Advanced English

3 years' QA experience

Problem solving

Herramientas

Minitab

PFMEA

DOE

Gage R&R

Descripción del empleo

Investigate 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 that require additional review for regulatory reporting.
• Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate 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 (i.e. sensor-cable-monitor).
• Review 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 if an investigation is required or not. Where investigation is needed, determine timelines with Failure Analysis Lab to ensure timely evaluation of product complaints and timely completion of reports. Reviews complaint investigation reports to ensure investigations are thorough and adequate and in accordance with procedures.
• Executes duties in compliance with established company policies.
• Develops a thorough understanding of the complaint database.

Perform other duties or special projects as assigned.

• Advanced english.
• VISA B1
• Minimum of 3 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 13485 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.