Sr. Software Qe

Abbott

Queretaro, Mexico
Not specified; base pyy n/a; range may vary by loc...
Onsite
5-6 years quality engineering experience
Fda gmp iso 13485 regulated environments
Non-product software validation lifecycle
Abbott is seeking a Senior Software Quality Engineer for its new manufacturing facility in Querétaro, Mexico, focusing on non-product software validation in the medical device sector. The ideal candidate will possess extensive experience in quality engineering, particularly within FDA-regulated environments, and be bilingual in English and Spanish

Job Summary

  • The Senior Software Quality Engineer will design and validate non-product software to ensure compliance with FDA regulations and medical industry standards.
  • This role involves leading cross-functional teams, managing test planning execution, and serving as the primary representative for external regulatory inspections.
  • Abbott offers career development opportunities within a recognized global healthcare company that is building a new manufacturing facility in Querétaro.

Matching Summary

Match Score: 85

Abbott is seeking a Senior Software Quality Engineer for its new manufacturing facility in Querétaro, Mexico, focusing on non-product software validation in the medical device sector. The ideal candidate will possess extensive experience in quality engineering, particularly within FDA-regulated environments, and be bilingual in English and Spanish.

Salary

Not specified; Base pay N/A; Range may vary by location

Skills & Requirements

Must-have

  • 5-6 years Quality Engineering experience
  • FDA GMP ISO 13485 regulated environments
  • Non-product software validation lifecycle
  • Bilingual English and Spanish proficiency
  • Software requirements test plans scripts reports

Nice-to-have

  • Six Sigma Belt or ASQ CQE CSQE certification
  • FDA Class II or III medical device experience
  • Cybersecurity knowledge for medical devices
  • ALCOA+ principles for data integrity
  • Cross-functional team leadership skills

Key Requirements

  • Bachelor's degree in Engineering Science or Technical Field
  • Minimum 5 years of experience in Quality or Manufacturing Engineering
  • Fully bilingual in English and Spanish
  • Knowledge of Part 11 Data Integrity and Cybersecurity
  • Proficiency in MS Excel Word PowerPoint

Work Rights

Not specified

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