Sr Director, Quality

Flex; Región Centro; Presencial; MXN 1.800.000 - 2.400.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive Salary

Life & Medical insurance

Christmas Bonus

Food Coupons

Saving Fund

Descripción de la vacante

Flex in Guadalajara, North Campus, seeks a Sr Director, Quality to lead global quality systems and ensure compliance with regulatory standards.

Reporting to VP Operations, the role requires building strategies, coordinating with cross-functional teams, and guiding quality initiatives across Americas, Europe, and Asia.

Ideal candidate has 10+ years in PCBA/manufacturing quality, strong regulatory experience, and a proven track record of audits and NPI.

Formación

• Bachelor’s degree in Engineering, Business Management, or related discipline; MBA preferred.
• 10+ years in PCBA/manufacturing quality with 7+ years leading teams.
• Strong knowledge of regulatory protocols and standards (ISO, FDA).
• Experience implementing a single quality system across multiple sites.
• Proven track record in regulatory audits and NPI processes.
• Ability to drive change across cultures and sites.

Responsabilidades

• Oversee and improve global quality systems across Americas, Europe, and Asia.
• Ensure compliance with ISO 13485 and other regulatory requirements.
• Lead QA teams and coordinate with legal, engineering, manufacturing, and customers.
• Drive regulatory strategy and continuous improvement initiatives.

Conocimientos

Regulatory compliance

Quality leadership

Cross-cultural collaboration

Strategic thinking

Educación

Bachelor's degree in Engineering or Business Management

MBA preferred

Herramientas

QMS (Quality Management System)

ISO 13485 familiarity

FDA regulatory knowledge

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.

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Sr Director, Quality located in Guadalajara, North Campus.

Reporting to the VP Operations, Sr Director, Quality will be responsible for guiding the quality function within Flex, with overall control for delivering a world‑class Quality System to the business and ensuring consistent, compliant best practices in key processes are applied across our organization. The position requires extensive interaction and strong liaison activities with internal management teams as well as externally with customers and regulatory agencies.

What a typical day looks like:

• Accountable for all aspects of building, maintaining, and improving quality systems including:
• Compliance, Customer Assurance (participation in customer project teams), and Document Control for manufacturing and design locations in the Americas, Europe, and Asia;
• Interface with manufacturing, engineering, quality and customer representatives to develop
• quality systems and ensure compliance, set on goals and solutions when required;
• Coach QA chiefs to develop effective system and compliance strategies that meet business goals.
• Provide proactive regulatory advice and expertise on a global basis to guide management
• Monitor the external landscape for QA to formulate strategies that are current and take into consideration the impact of business choices;
• Work closely with industry bodies globally to ensure compliance;
• Continuously review and put strategies in place to improve existing processes and promote
• implementation of new initiatives across the organization’s regulatory function to ensure consistency, compliance and best practice;
• Ensure compliance with the Company’s Quality System and applicable regulatory requirements
• such as ISO 13485;
• Prepare the Company for regulatory inspections;
• Work closely with Sr. functional chiefs (e.g. Legal, Quality Assurance, Marketing, Engineering,
• Manufacturing, Service) to implement quality and regulatory strategies consistent with the business vision;
• Develops, establishes and maintains quality assurance programs, policies, processes, procedures
• and controls ensuring that performance and quality of products conform to established standards, agency guidelines and customer requirements that where ever appropriate are consistent across multiple locations;
• Works directly with operating entities to ensure the conduct of inspections, statistical process
• control research and audits on a continuing basis as specified to enforce requirements and meet specifications;
• Establishes and ensures compliance with good housekeeping practices, employee hygiene and
• equipment sanitation; investigate plant error, salvage, spoilage reports and process statistics for significant findings and conclusions; works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes;
• May serve as the Management Representative for the designated business and associated site(s).

The Experience we are looking to add to our team:

• Bachelor’s degree in Engineering, Business Management, or related discipline; MBA preferred.
• 10+ years in PCBA/manufacturing Quality, with 7+ years leading teams/programs.
• Strong knowledge of regulatory protocol and process (such as ISO, FDA certifications);
• Demonstrated success in creating strategies to guide a team to success;
• Must be thoroughly familiar with the quality requirements associated with developing products in a regulated industry.
• Experience implementing a single quality system across multiple sites.
• Proven track record of successful regulatory audits;
• Demonstrated experience with a New Product Introduction process (i.e. new product launches);
• Strong knowledge of assigned business operations and knowledge of product specific safety standards and work groups;
• Strong problem solving and negotiation skills with the ability to develop and implement complex influencing and negotiating strategies that demonstrate political awareness. Ability to work across cultures/poles/sites;
• Demonstrated ability to drive change, test the status quo and promote new activities, stimulating others to change and manage implementation effectively;
• Knowledge of current commercial or political situations and their impact on the organizations regulatory strategies.

What you’ll receive for the great work you provide:

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

MG61

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. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email [e-mail] 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).