Senior Quality Engineer - Medical Devices & ISO 13485

jabil; Ecatepec de Morelos; Presencial; MXN 180.000 - 240.000; Jornada completa

Descripción de la vacante

Jabil seeks a Quality Engineer to lead the Workcell QA operations and support the NPI team, ensuring product quality and regulatory compliance. You will drive quality plans, perform statistical analysis, and collaborate with manufacturing, engineering, and suppliers to resolve discrepancies.

The role requires a Bachelor’s degree with 7+ years in quality engineering and fluent English. Experience in medical device manufacturing and CAPA leadership is preferred; a CQE is a plus.

Formación

• Bachelor’s degree required; seven years related experience or equivalent.
• Proficiency in English, written and verbal.
• Experience in Medical Device industry and ISO 13485 knowledge.
• Certified Quality Engineer preferred (ASQ CQE).
• Strong problem solving and data analysis skills.

Responsabilidades

• Lead quality evaluation plans and protocols for materials and products.
• Develop and implement methods for inspecting and testing production.
• Support quoting in early design and development phases.
• Lead quality operations activities for product release testing.
• Approve batch records and revise manufacturing processes.
• Act as Validation Owner for validation activities.
• Ensure ISO 13485 CFR 21 Part 820 compliance and CAPA closure.
• Supervise QA Engineers, Inspectors, and Technicians.
• Participate in FDA quality audits as needed.

Conocimientos

Problem solving

Negotiation skills

English proficiency

Minitab

Quality statistics tools

Educación

Bachelor’s degree

Herramientas

Minitab

Quality statistics tools

Descripción del empleo

Jabil seeks a Quality Engineer to lead the Workcell QA operations and support the NPI team, ensuring product quality and regulatory compliance. You will drive quality plans, perform statistical analysis, and collaborate with manufacturing, engineering, and suppliers to resolve discrepancies.

The role requires a Bachelor’s degree with 7+ years in quality engineering and fluent English. Experience in medical device manufacturing and CAPA leadership is preferred; a CQE is a plus.