Flex Quality Manager Regulatory Compliance Medical Devices 

Mexico, Baja California, Tijuana 

713200782

located in
Tijuana Site.

Reporting to the Quality Director

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..
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
• 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.