QA Engineer II — Medical Devices, CAPA & Compliance

Merit Medical; Tijuana; Presencial; MXN 524.475 - 874.126; Jornada completa

Descripción de la vacante

Merit Medical in Tijuana seeks a Quality Engineer to manage risk documentation and ensure quality control in medical device production. Candidates should hold a Bachelor's Degree in Engineering and have at least three years of experience in the medical field.

The role requires strong interpersonal skills, knowledge of quality standards, and proficiency with statistical methodologies. Applicants must demonstrate the ability to work effectively in a team.

Formación

• 3 years of quality engineering experience in medical devices.
• Advanced English level required.
• Demonstrated knowledge of 21 CFR 820 and ISO standards.

Responsabilidades

• Evaluate engineering techniques and make adaptations.
• Manage risk documentation for product lines.
• Review Engineering Change Notifications (ECNs).

Conocimientos

Quality engineering in medical devices

Statistical methodologies

Lean manufacturing

Six Sigma

Interpersonal communication

Educación

Bachelor's Degree in Engineering or related field

Herramientas

MS Excel

Database software

Descripción del empleo

Merit Medical in Tijuana seeks a Quality Engineer to manage risk documentation and ensure quality control in medical device production. Candidates should hold a Bachelor's Degree in Engineering and have at least three years of experience in the medical field.

The role requires strong interpersonal skills, knowledge of quality standards, and proficiency with statistical methodologies. Applicants must demonstrate the ability to work effectively in a team.