Quality Engineer Microbiology and Sterilization (Medical Devices) (Ciudad Juárez)

Quality Engineer Microbiology and Sterilization (Medical Devices) (Ciudad Juárez)

06 ago
|
Flex
|
Ciudad Juárez

06 ago

Flex

Ciudad Juárez

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.
Job Summary
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Quality Engineer Microbiology and Sterilization located in Juarez Sur
Reporting to the Quality Director, the Quality Engineer Microbiology and Sterilization’s role 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, and regulatory/compliance agency 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
EM57
Job Category
Design, Process & Technology Engineering
**Required Skills**:
Optional Skills:

📌 Quality Engineer Microbiology and Sterilization (Medical Devices) (Ciudad Juárez)
🏢 Flex
📍 Ciudad Juárez

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