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We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.
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
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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
- 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
- Competitive Salary.
- Life & Medical insurance.
- Christmas Bonus.
- Food Coupons.
- Saving Fund.
Job Category
Quality
Required Skills:
Optional Skills:
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and 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).