Senior Quality Engineer – Medical Devices Compliance

Baxter International Inc.; Tijuana; On-site; MXN 420,000 - 700,000; Full time

Job summary

Baxter International Inc. in Mexico is seeking a Senior Engineer, Quality to establish and maintain quality control systems for designated areas. You will coordinate scheduling of quality resources and ensure compliance with regulatory requirements and product specifications.

The role involves leading quality projects, data analysis from field data, and supporting sustainment and validation activities. The position requires a B.S.

Qualifications

• B.S Degree in Engineering or equivalent experience required.
• Two to Three years in similar positions.
• Training - Knowledge of risk management ISO13485.
• Formal education or training in quality control techniques, including quality system audits, statistical tools, design of experiments, statistical sampling methods and testing methods, Lean principles, etc.
• Desired knowledge in regulatory requirements for medical devices and standards, including FDA medical device rules outlined in Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC, and EUMDR

Responsibilities

• Ensure compliance with QSR part 820, ISO-13485 and other applicable laws.
• Ensures and reports on metrics to supervise quality performance.
• Ensure that the non-conforming material process is carried out following established procedures and adhering to driven metrics.
• Support with the creation, maintenance and where applicable improvement of work instructions
• Support with validation activities, IQs, TMVs, OQs, PQs, for designated areas
• May lead or participate in NCR, SNCR, CAPA activities adhering to established procedures while ensuring compliance with quality objectives.
• Assist management and departmental staff in the implementation of statistical methods for quality assurance to improve operational efficiency and effectiveness.
• Responsible for the analysis of data acquired from the field to investigate and resolve issues identified through Post Market Surveillance Report.
• Participates in project transfer, through the identification and correction of gaps identified in the manufacturing processes, establishing product acceptance criteria, ensuring quality controls and supporting project deadlines.
• Participates in Value Stream projects (quality improvements, cost savings, efficiency gains).
• Ensure that all inspection and test specifications are accurately performed and detailed.
• Conduct a root cause analysis to prevent recurrence.
• Supervise and coordinate the function of the Quality Technicians and Quality Intern.
• Conducts routinely internal audits, Gemba’s, LTTs pertaining to the quality system in compliance with procedures. Reports audit results for management.
• Guarantees alignment with assigned critical metrics and notifies management of any possible impact.
• Supports analysis, investigation and field actions. Builds consignees list and contacts clients to acquire required information.
• Composes, monitors and ensures consistency with quality plans.

Skills

Quality control

Regulatory knowledge

Auditing

Lean principles

Statistical tools

Design of experiments

Risk management

Gemba Walks

Education

B.S Degree in Engineering

Tools

ISO13485 training

Job description

Baxter International Inc. in Mexico is seeking a Senior Engineer, Quality to establish and maintain quality control systems for designated areas. You will coordinate scheduling of quality resources and ensure compliance with regulatory requirements and product specifications.

The role involves leading quality projects, data analysis from field data, and supporting sustainment and validation activities. The position requires a B.S.