Senior Quality Engineer, Medical Devices & CAPA

Intuitive; Mexicali; Presencial; MXN 600.000 - 800.000; Jornada completa

Descripción de la vacante

Intuitive is seeking a Quality Engineer in Mexicali to ensure compliance with ISO 13485 and 21 CFR820. You will monitor notifications, validate processes, and drive defect reduction across manufacturing lines for medical devices.

The role requires 5+ years in quality engineering within the medical industry, with strong CAPA and auditing experience. Responsibilities include trend analysis, CAPA closure, and cross-functional collaboration with Manufacturing and QA teams.

Formación

• Bachelor's degree in engineering required.
• English Advanced required.
• Office software proficiency (Office Suite) required.
• SAP knowledge at intermediate level.
• Minitab knowledge at intermediate level is desirable.
• Quality Engineer or Manufacturing experience in medical devices (≥5 years).
• Experience in process validations (≥5 years).
• Experience in quality audits for medical products (≥3 years).
• Experience in the medical industry (≥3 years).
• Lean Manufacturing experience (≥3 years).
• ISO-13485, 21 CFR820 knowledge (≥3 years).
• Troubleshooting skills (CAPA, 5 Whys, Fishbone, 8D) (≥3 years).
• Six Sigma and statistical tools (DOE, SPC, PFMEA, MSA) (≥3 years).

Responsabilidades

• Follow up on quality notifications (VRs, NCRs, etc.) and perform trend analysis.
• Participate in health and safety-related activities when required.
• Use devices, tools, and equipment per process; report defective items.
• Communicate unsafe acts or conditions to supervisors.
• Maintain workstation order and cleanliness (5S).
• Prepare trend reports and CAPA analyses.
• Follow up on quality notifications affecting Mexicali and corporate locations.
• Develop lines, processes, or product validations and document results in SAP/Agile.
• Drive defect reduction projects and mentoring for new quality engineers.
• Complete ISU training and MERIT self-assessments.

Conocimientos

English Advanced

Lean Manufacturing

Six Sigma

Troubleshooting CAPA

ISO-13485 knowledge

Medical quality experience

Educación

Bachelor's Degree in Engineering

Herramientas

SAP

Minitab

Descripción del empleo

Intuitive is seeking a Quality Engineer in Mexicali to ensure compliance with ISO 13485 and 21 CFR820. You will monitor notifications, validate processes, and drive defect reduction across manufacturing lines for medical devices.

The role requires 5+ years in quality engineering within the medical industry, with strong CAPA and auditing experience. Responsibilities include trend analysis, CAPA closure, and cross-functional collaboration with Manufacturing and QA teams.