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 ***** 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 *****, 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, versátil 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.
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📌 Sr. Quality Engineer - Nogales (Heroica Nogales)
🏢 Kimberly-Clark
📍 Heroica Nogales