At Flex, we welcome people of all backgrounds.
Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always.
Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose - to make great products that create value and improve people's lives.
- Job Summary
- At Flex, we welcome people of all backgrounds.
Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always.
- Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose to make great products that create value and improve people's lives.
- Job summary:
- To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Sterilization Engineer located in Tijuana, BC.
- Reporting to the Quality Manager, the Sterilization Engineer role involves maintains quality engineering programs, standards and improvements within the organization
- What a typical day looks like:
- Develops and initiates procedures for sterilization release and validation.
- Implementation of endotoxin testing laboratory
- Validate endotoxin testing processes
- Create documentation for endotoxin testing process control
- Supervise laboratory technicians
- Coordination and evaluation of non-conformant product disposition related with sterilization excursions.
- Support workers engaged in monitor sterilization metrics.
- Provide training to workers related with sterilization process.
- Supports Product Engineers and Quality Program Managers with customer interfaces as necessary on quality-sterilization related issues.
- 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.
- Coordinate sterilization validation projects through meetings with customers and sterilizers.
- Initiates corrective action requests as needed and tracks to satisfactory completion.
- Assists with quality audits
- Analyzes reports and returned products and recommends corrective action.
- Support Engineering and Quality areas in projects where sterilization needs to be evaluated; such change of materials, change of raw material supplier locations, etc.
- Develops procedure for bioburden, dose audits and endotoxin testing.
- Coordinate endotoxin testing activities.
- Review and approve endotoxin, bioburden, dose audits and sterilization reports.
- The experience we're looking to add to our team:
- Require a Bachelor's Degree or equivalent experience.
- Knowledge in ethylene oxide and radiation sterilization processes
- Ability to evaluate data related with sterilization; such sterilization run records, sterility results, bioburden, dose audits and endotoxin reports.
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Ability to coordinate root cause analysis
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
- Ability to write reports, business correspondence and procedures.
- Ability to effectively communicate with managers and employees of the organizations.
- Demonstrates advanced operations, technical and people and/or process skills as well as customer (external and internal) relationship skills.
- Ability to understand Quality System
- Ability to coordinate sterilization projects
- Conversational and written English and Spanish skills
- What you'll receive for the great work you provide:
- Competitive Salary.
- Life & Medical insurance.
- Christmas Bonus.
- Food Coupons.
- Saving Fund.
- LB17
- Job Category
Quality