Quality Assurance Engineer I — Grow with Medical Devices

Merit Medical Systems, Inc.; Tijuana; Sur place; MXN 420 000 - 540 000; Plein temps

Résumé du poste

Merit Medical Systems, Inc. in Mexico (Tijuana) seeks a Quality Engineer to support compliance with 21 CFR 820, ISO 13485, and CAPA processes across product lines. You will lead risk management documentation, partake in supplier audits, review ECNs, and drive containment of nonconforming product while maintaining the quality management system.

Strong collaboration and problem-solving skills are essential. This role involves analyzing data, supporting design activities, and working in a regulated

Qualifications

• Education and/or experience equivalent to a Bachelor’s Degree in Quality Engineering or related field, or a Master’s Degree.
• Strong interpersonal, organizational, and verbal and written communication skills.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14791 and related medical device standards.
• Ability to work effectively in a team and resolve conflicts.
• Familiarity with statistical methods, quality tools, lean, and Six Sigma.
• Computer skills with spreadsheets, word processing, databases, and similar software.

Responsabilités

• Performs routine engineering work applying standard techniques and criteria.
• Reviews ECNs to update/verify methods, procedures, and test protocols.
• Participates in supplier quality audits and monitors supplier performance.
• Reviews nonconformance records to determine disposition and root cause.
• Ensures containment of nonconforming product and maintains the quality system.
• Supports changes to maintain suitability and effectiveness of the quality management system.

Connaissances

Quality standards

Statistical methods

Lean manufacturing

Six Sigma

Data analysis

Teamwork

Formation

Bachelor's/master in Quality Engineering

Outils

Oracle

Crystal Reports

SmartCAPA

Description du poste

Merit Medical Systems, Inc. in Mexico (Tijuana) seeks a Quality Engineer to support compliance with 21 CFR 820, ISO 13485, and CAPA processes across product lines. You will lead risk management documentation, partake in supplier audits, review ECNs, and drive containment of nonconforming product while maintaining the quality management system.

Strong collaboration and problem-solving skills are essential. This role involves analyzing data, supporting design activities, and working in a regulated