Quality Manager Regulatory Compliance ( Medical Devices) Job Listing at Flex in Tijuana, B.C. (Job ID WD196450)

Description

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. 

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.

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..
• 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.

GR66

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).