QA Engineer I, Medical Devices | Risk & Quality Control

Merit Medical Systems; Tijuana; On-site; MXN 240,000 - 300,000; Full time

Benefits offered by this job

Medical Insurance

Onsite Clinic

Cafeterias

Job summary

Merit Medical Systems is seeking a Quality Assurance Engineer I to perform routine engineering tasks within established methods and to support risk management for assigned product lines at our Tijuana site.

The role emphasizes adherence to 21 CFR 820, ISO 13485, and related medical device standards, with opportunities to participate in ECNs, supplier audits, and CAPA activities. Onsite work with cross-functional collaboration is required.

Qualifications

• Bachelor's degree in Quality Engineering or related field; Master’s preferred.
• Strong interpersonal, organizational, and verbal/written communication skills.
• Knowledge of 21 CFR 820, ISO 13485, and other medical device standards.

Responsibilities

• Perform routine engineering work using standard techniques and criteria.
• Assist with risk management and failure mode analysis for product lines.
• Review ECNs and update verification, validation, and inspection methods.
• Participate in supplier quality audits and containment of nonconforming product.
• Support CAPA investigations and corrective actions within QMS.

Skills

Quality engineering

ISO 13485

21 CFR 820

Six Sigma

Data analysis

CAPA

Quality systems

Education

Bachelor's degree in Quality Engineering

Master's degree

Tools

Excel

Crystal Reports

Oracle

Quality management software

Job description

Merit Medical Systems is seeking a Quality Assurance Engineer I to perform routine engineering tasks within established methods and to support risk management for assigned product lines at our Tijuana site.

The role emphasizes adherence to 21 CFR 820, ISO 13485, and related medical device standards, with opportunities to participate in ECNs, supplier audits, and CAPA activities. Onsite work with cross-functional collaboration is required.