Senior Investigator

Key Responsibilities The Senior Quality Investigator is responsible for conducting thorough investigations of customer complaints, internal non-conformances, and other quality-related issues within a Medical Device environment. The role ensures compliance with regulatory standards and internal procedures, aiming to identify root causes and implement corrective and preventive actions (CAPA). This Quality position collaborates directly with Manufacturing, Engineering, Supply Chain, Quality Platform, R&D, Design assurance, Technical Services, Customer and Suppliers to ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks. Additional Skills & Qualifications Position requires a sound Quality or technical/Engineering background. Master of Science in Quality Assurance or Master of Science in Engineering or science discipline. Professional English (written and oral) Minimum of 5 years of experience in a medical device or regulated industry. Proven experience in writing deviations, investigating CAPAs. Excellent analytical and problem-solving skills. Proficiency in technical writing and documentation Ability to work self-directed at a fast pace dealing with multiple tasks. Ability to influence in a matrix organization Analytical - Synthesizes complex or diverse information. High positive energy to take on continuous and complex business challenges in a fast-paced environment. Persistence to drive to solutions despite obstacles and/or competing priorities. Teamwork skills: Ability to work with diverse teams across the organization. Judgment and decision-making skills supported by sound technical & business justification. Demonstrated ability to discuss both technical and business issues with all levels of management, Customers and Suppliers. Statistical knowledge Willing to travel at customer, suppliers or other sites upon request.

Location: Naucalpan de Juárez, MX

Posted Date: 4/30/2025