Senior QA Design Transfer Engineer – Medical Devices

Merit Medical Systems; Tijuana; Híbrido; MXN 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Onsite Clinic

Onsite Cafeterias

Vacation & Holidays

401K

HSA

Descripción de la vacante

Merit Medical Systems in Tijuana, Mexico is seeking an experienced Design Quality Engineer to lead design controls, risk management, and quality system activities for medical device products. You will review ECNs, support process validation, and mentor engineers and technicians to ensure compliance with 21 CFR 820, ISO 13485, and related standards.

The role requires a Bachelor's in Engineering, at least 8 years in medical device or regulated industries, strong statistics knowledge, and

Formación

• Degree in engineering or related field with strong regulatory knowledge.
• Minimum eight years of engineering experience in medical devices or regulated industry.
• Experience with design control, QC tools, and statistical methodologies.

Responsabilidades

• Lead design control activities from inputs to design outputs and change management.
• Coordinate risk analysis/management and ensure mitigation actions.
• Review and generate ECNs for verification/validation and procedures.
• Support internal and supplier audits and improve quality systems.

Conocimientos

Quality systems knowledge

Statistical methods

Lean manufacturing

Six Sigma

Regulatory knowledge

Project management

Problem solving

Educación

Bachelor's Degree in Engineering or related field

Herramientas

Minitab

JMP

Oracle

Descripción del empleo

Merit Medical Systems in Tijuana, Mexico is seeking an experienced Design Quality Engineer to lead design controls, risk management, and quality system activities for medical device products. You will review ECNs, support process validation, and mentor engineers and technicians to ensure compliance with 21 CFR 820, ISO 13485, and related standards.

The role requires a Bachelor's in Engineering, at least 8 years in medical device or regulated industries, strong statistics knowledge, and