Sr. Quality Engineer - Nogales

Kimberly-Clark Corporation; Heroica Nogales; Presencial; MXN 520.000 - 700.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental coverage

Vision coverage

On-site fitness center

Occupational health nurse

Flexible savings accounts

Income protection insurance

Education and relocation support

Descripción de la vacante

Kimberly-Clark Corporation in Nogales seeks a Sr. Quality Engineer to support medical device operations. You will review validation protocols, lead QA activities and ensure compliance with FDA/GMP and ISO 13485 standards.

The role involves leading the quality engineering team, conducting investigations, calibration management, and implementing corrective actions to improve product quality and process capability.

Formación

• 4+ years of quality management experience for medical devices.
• Strong knowledge of statistics and process capability.
• Experience with problem-solving tools (5 Whys, Ishikawa, RCA).
• Exposure to validation processes (IQ/OQ/PQ, MVP).
• Advanced English proficiency and leadership experience.

Responsabilidades

• Review and approve validation protocols for equipment.
• Lead quality engineering team to ensure compliance with standards.
• Coordinate inspections, investigations, and corrective actions.
• Maintain calibration management and testing of equipment.
• Ensure compliance with FDA, GMP and ISO 13485.

Conocimientos

Advanced English

Statistics & SPC

Problem-solving tools

Quality management

Leadership

Educación

Industrial Engineering degree

Herramientas

Minitab

Ishikawa

RCA

PPK

Descripción del empleo

Sr. Quality Engineer - Nogales

We are looking for an experienced quality engineer to support our medical device operations. Responsibilities include review and approval of validation protocols, adherence to FDA/GMP/ISO 13485 standards, incident investigations, calibration management, corrective actions, and leading a quality engineering team.

Responsibilities

• Review and approve validation protocols for new and existing equipment.
• Participate in planned inspections and investigations of accident incidents for the EHS system.
• Assist the Manager of Quality Assurance in planning, organizing quality department activities and maintaining standards according to FDA and GMP.
• Coordinate, review and apply methods of material and process inspection using approved procedures.
• Develop, validate and verify test methods for products and processes.
• Execute and control calibration and test equipment to ensure reliable measurements.
• Contribute to corrective actions and client claims investigations.
• Maintain controlled environment and comply with security requirements.
• Analyze statistics to monitor non‑conforming products and compute DPM of receipt, process and packaging.
• Provide training and maintain training needs system.
• Ensure compliance with quality standards and regulations (ISO 13485, FDA/GMP).
• Lead the quality engineering group to ensure compliance with validation requirements and product specifications.
• Improve inspection processes and sampling plans.
• Lead improvement projects with the greatest plant impact.

Qualifications

• Graduate professional in Industrial Engineering or related engineering discipline.
• Minimum 4 years of experience in quality management for medical devices.
• Strong knowledge of statistics & process capability (Minitab, PPK, hypothesis testing).
• Experience with problem‑solving tools (5 Whys, Ishikawa, RCA).
• Exposure to validation processes (IQ/OQ/PQ, MVP, etc.).
• Advanced English level.
• Previous people‑leadership experience.

Benefits

Medical, dental and vision coverage, on‑site fitness center, occupational health nurse, flexible savings and spending accounts, income protection insurance, education and relocation support.

EEO Statement

Kimberly‑Clark is a committed equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law.