Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.
A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.
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:
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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
- 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.
- Pantry vouchers
- Saving Fund
- Christmas bonus
- Holiday bonus
- Medical Insurance
- Life Insurance
Job Category
Design, Process & Technology Engineering
Required Skills:
Optional Skills:
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).