Quality Assurance Specialist for Sterilization Process

hace 4 semanas


Tijuana, Baja California, México Flex A tiempo completo
Sterilization Quality Assurance

Flex is seeking a highly skilled Sterilization Quality Assurance Specialist to join our team in Tijuana, Mexico. This individual will play a critical role in ensuring the quality of our sterilized products by developing and implementing procedures for sterilization release and validation.

About the Role

This position requires a deep understanding of sterilization processes, including ethylene oxide and radiation methods. The ideal candidate will have a strong background in quality assurance and be able to analyze data to ensure compliance with regulatory requirements.

Key Responsibilities:
  • Develop and implement procedures for sterilization release and validation.
  • Coordinate and evaluate non-conformant product disposition related to sterilization excursions.
  • Support workers engaged in monitoring sterilization metrics.
  • Provide training to workers related to sterilization process.
  • Review and analyze bioburden and dose audits data.
  • Review and analyze endotoxin testing results.
  • Coordinate and conduct sterilization validation process for ethylene oxide and radiation methods.
  • Initiate corrective action requests as needed and track to satisfactory completion.
Requirements:
  • Advanced English language skills.
  • Bachelor's degree or equivalent experience.
  • Proficient in using Office software (Word, Excel, PowerPoint, etc.).
  • Effective communication and escalation skills.
  • Understanding of EO and radiation concepts.
  • Ability to classify product and process defects and nonconformities.
  • Knowledge of Quality System concepts.
What We Offer:
  • Pantry vouchers.
  • Saving Fund.
  • Christmas bonus.
  • Holiday bonus.
  • Medical Insurance.
  • Life Insurance.

The estimated salary for this role is $80,000 - 100,000 USD per year, depending on experience and qualifications. If you are a motivated and detail-oriented professional looking to make a difference in the field of quality assurance, we encourage you to apply.



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