Quality Manager Regulatory Compliance ( Medical Devices)

Financecolombia; Tijuana; Presencial; MXN 1,116,000 - 1,490,000; Jornada completa

Descripción de la vacante

An innovative manufacturing partner is seeking a Quality Manager for our Tijuana site. This role involves overseeing quality assurance processes, managing regulatory submissions, and leading audits to ensure compliance with ISO 13485 and FDA regulations. The ideal candidate will possess a Bachelor's degree, ISO 13485 certification, and advanced English skills, while driving improvements to maintain our high standards.

Servicios

Competitive Salary

Life & Medical insurance

Christmas Bonus

Food Coupons

Saving Fund

Formación

• Experience leading audits (ISO, FDA).
• Ability to apply mathematical operations related to quality management.
• Strong ability to work independently and meet deadlines.

Responsabilidades

• Develops and initiates inspection and testing standards.
• Leads internal and external audits.
• Compiles and reports quality data.

Conocimientos

ISO 13485 auditing

Project management

Advanced English

Educación

Bachelor's degree in related field

Descripción del empleo

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 don't 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, we’re looking to add a Quality Manager located at the Tijuana Site.

Reporting to the Quality Director, this role will be responsible for preparing and coordinating 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 products 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.
• Ensures 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.
• Leads or supports key regulatory projects including ISO 13485 and FDA regulations.
• Leads internal and external audits.
• Maintains and improves TJ Site Quality procedures.
• Has a strong background in CAPA management and root cause analysis tools.
• Serves as a Deputy of the Director as appropriate.
• Leads and drives improvements across the site to mitigate risks.

Education and experience requirements

Here is some of what you’ll need (required):

• Typically requires a bachelor’s degree in a related field or equivalent work experience.
• Ability to apply mathematical operations to tasks such as frequency distribution, test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• Experience leading audits (ISO, FDA).
• Certified ISO 13485 Auditor (MUST).
• Desirable: ASQ Certification.
• Advanced English skills (written and spoken).
• Strong ability to work independently, manage multiple projects, and meet deadlines.

What you’ll receive for your great work:

• Competitive Salary.
• Life & Medical insurance.
• Christmas Bonus.
• Food Coupons.
• Saving Fund.

GR66

Job Category: Quality

Flex is an Equal Opportunity Employer and employment 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, or any other status protected by law. We’re happy to provide reasonable accommodations for those with disabilities during the application process. Please email [e-mail]. Note: this email is only for disability assistance. To be considered for a position at Flex, you must complete the application process first.