Flex Quality Engineer Microbiology Sterilization Medical Devices 

Mexico, Guanajuato 

392858466

Job Summary

Reporting to the, therole involves:

What a typical day looks like:

• Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.
• Develops initial and subsequent modifications of Design Quality Assurance program to delineate areas of
• Interface with customers on technical/quality issues and improvement initiatives.
• In charge of managing customer audits, internal audits, andregulatory/complianceagency audits.
• Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
• Visits and confers with representatives of material and component vendors to obtain information related to supply quality.
• Develop and validate sterilization methods (e.g., ethylene oxide, steam, gamma radiation) for medical devices and pharmaceutical products.
• Conduct microbiological testing and evaluate the effectiveness of sterilization protocols.
• Perform routine environmental monitoring and microbiological assessments in manufacturing areas.
• Initiate and lead investigations into product quality issues and non-conformances related to microbiology.
• Collaborate with R&D and manufacturing teams to ensure microbiological safety throughout the product lifecycle.
• Develop and maintain standard operating procedures (SOPs) related to microbiological testing and sterilization processes.
• Analyze data and prepare reports for regulatory submissions and audits.
• Stay current with industry trends and regulatory guidelines related to sterilization and microbiology.
• Experience in Medical Devices

The experience we’re looking to add to our team:

• Advanced English
• Bachelor’s degree in Microbiology, Biomedical Engineering, Quality Assurance, or a related field (Master’s degree preferred).
• Experience in Quality Engineering or Microbiology within a regulated industry (e.g., medical devices, pharmaceuticals).
• Knowledge of ISO 13485, FDA regulations, and AAMI/ISO standards.
• Experience with microbiological testing techniques and sterilization validation processes.
• Strong analytical skills and proficiency in statistical process control.
• Excellent communication and teamwork abilities.

What you’ll receive for the great work you provide:

• Pantry vouchers
• Saving Fund
• Christmas bonus
• Holiday bonus
• Medical Insurance
• Life Insurance

Job CategoryDesign, Process & Technology Engineering

Required Skills:

Optional Skills: