Senior Quality Engineer: Medical Device Design & Risk

ICU Medical; Tijuana; Presencial; MXN 1,281,000 - 1,649,000; Jornada completa

Descripción de la vacante

A leading medical device company in Tijuana, Mexico seeks an experienced Sr. Quality Engineer. The role involves ensuring product compliance with quality standards and regulations, utilizing quality tools, and coordinating with cross-functional teams. The ideal candidate has a Bachelor's degree in engineering, 7+ years of experience in the medical device industry, and strong bilingual communication skills. This position offers an opportunity to impact product quality significantly.

Formación

• 7+ years of experience in a similar role within the medical device industry.
• Hold ASQ CQE or CSQE certification or ability to obtain within one year.
• Strong knowledge of ISO 13485, ISO 14971, FDA regulations, and key medical device standards.
• Bilingual Spanish/English communication skills.

Responsabilidades

• Ensure compliance with quality standards and regulations.
• Utilize quality tools for process and product analysis.
• Coordinate product changes and work with cross-functional teams.
• Monitor product data to identify trends and risks.

Conocimientos

Quality assurance

Risk analysis

Regulatory compliance

Cross-functional teamwork

Statistical data analysis

Educación

Bachelor's degree in engineering

Descripción del empleo

A leading medical device company in Tijuana, Mexico seeks an experienced Sr. Quality Engineer. The role involves ensuring product compliance with quality standards and regulations, utilizing quality tools, and coordinating with cross-functional teams. The ideal candidate has a Bachelor's degree in engineering, 7+ years of experience in the medical device industry, and strong bilingual communication skills. This position offers an opportunity to impact product quality significantly.