Quality Manager Regulatory Compliance ( Medical Devices)
Quality Manager Regulatory Compliance ( Medical Devices)
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Job Description
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 dont 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 were 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 youll need (required):
- Typically requires a bachelors 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 youll receive for the great work you provide:
- Competitive Salary.
- Life & Medical insurance.
- Christmas Bonus.
- Food Coupons.
- Saving Fund.
GR66
Job Category
QualityRequired 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. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well 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).
Required Experience:
Manager
Employment Type
Full-Time
