Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Sr. Manager QA

Become a Sr. Manager QA at Thermo Fisher Scientific in our Apodaca manufacturing site. Contribute to regulatory compliance and quality assurance. Lead the QA team and maintain flawless operations according to national and international standards.

What will you do?

• Ensure the Quality Management System is detailed, applied, and effective, aligning strictly with ISO standards and FDA regulations.
• Review new and existing product specifications, claims, and announcements for regulatory compliance, maintaining all supporting materials and documentation.
• Liaise with external parties, including clients and regulatory bodies, on matters related to quality systems and audits.
• Manage the internal audit system, including the selection and training of internal auditors to maintain our ambitious quality standards.
• Direct and supervise the Quality Engineering group, ensuring procedures and work instructions are strictly followed in areas such as quality control-Receipt, quality control-RGA, and quality control-Production.

• Provide quality inspection support in warehouse product audits, ensuring customer complaints are analyzed and resolved successfully.
• Maintain quality control inspection plans during new product validation processes.
• Support Quality Engineers in issuing NCRs and implementing corrective measures.
• Coordinate initiatives to improve quality, with a strong emphasis on cost savings, method improvements, reducing scrap, controlling NCR, and addressing safety concerns.
• Manage the quality control system in support of Inspection and Process Control, developing and maintaining relevant documentation.
• Collaborate with various functional areas to manage the validation process, ensuring processes are successfully implemented and released to production.

• Bachelor's degree in technology, engineering, Administration, or a related field.
• Minimum of 5 years of experience in the plastic molding environment, with proven expertise in developing quality systems aligned with ISO 13485/9001 and FDA regulations.
• Bilingual proficiency in Spanish and English.
• Certification from the American Society for Quality or equivalent, with practical knowledge of ISO-9001, ISO 13485 standards, and cGMP.
• Experience working with SAP platforms is highly desirable.