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 Manager located in Tijuana Site.
- Reporting to the Quality Director This role will be prepare and coordinate efforts to support customers in regulatory submissions
- What a typical day looks like:
- Develops and initiates standards and methods for inspection, testing and evaluation.
- Devises sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data.
- Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost.
- Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.
- Compiles and writes training material and conducts training sessions on quality control activities.
- Holds up Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues.




- Assures data availability and integrity for all quality related data. Consolidates and reports quality results.
- Initiates corrective action requests as needed and tracks to satisfactory completion.
- Lead or support key regulatory projects including ISO 13485 and FDA regulation
- Lead of Internal and External Audits
- Mantain and improve TJ Site Quality procedures
- Strong Background on CAPA Management, Root Cause Analysis Tools
- Serve as a Deputy of the Director as appropiate
- Lead and Drive improvements across the site to mitigate any risk
- Education and experience requirements
Here is some of what you’ll need (required):
- Typically requires a bachelor’s degree in related field or equivalent work experience..
- Experience leading audits (ISO, FDA)
- Ceritfied ISO 13485 Auditor (MUST)
- Desirable ASQ Certiffied
- Advanced English (written, spoken)
- Strong ability to work independently, manage multiple projects and meet deadlines
- What you’ll receive for the great work you provide:
- Competitive Salary.
- Life & Medical insurance.
- Christmas Bonus.
- Food Coupons.
- Saving Fund.
- GR66
Job Category
Quality
**Required Skills**:
Optional Skills:

📌 Quality Manager Regulatory Compliance (Medical Devices) (Tijuana)
🏢 Flex
📍 Tijuana