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.

Quality Engineer (Medical Devices) - Tijuana

Reporting to the Quality Manager , the Quality Engineer’s role involves:

What a typical day looks like:

- Monitor manufacturing processes and quality performance metrics to ensure compliance with approved procedures, product specifications, and applicable regulatory requirements such as FDA QMSR, ISO 13485, and internal quality system standards.
- Develop, implement, and continuously improve inspection methods, test protocols, acceptance criteria, and statistical techniques to verify product conformity and process effectiveness throughout the manufacturing lifecycle.
- Analyze nonconforming material reports (NCMRs), customer complaints, yield trends, and quality system data to identify recurring issues, investigate root causes, and drive effective corrective and preventive actions (CAPA).
- Lead and participate in cross-functional investigations related to product defects, process deviations, supplier quality concerns, and customer-reported issues utilizing structured problem-solving methodologies such as 5 Why, Fishbone Diagram, and Failure Mode and Effects Analysis (FMEA).
- Review and approve manufacturing and quality documentation including inspection procedures, control plans, validation protocols, work instructions, test methods, and engineering change orders to ensure compliance with quality and regulatory requirements.
- Support process validation, equipment qualification, and product transfer activities by reviewing protocols, analyzing data,



and ensuring all acceptance criteria are achieved prior to implementation.
- Partner closely with Manufacturing, Operations, Process Engineering, Supplier Quality, and Customer Quality teams to improve product quality, reduce defects, and enhance overall process capability.
- Perform statistical analysis of manufacturing and quality data using tools such as SPC, trend analysis, capability studies, and sampling plans to identify areas for improvement and support data-driven decision making.
- Evaluate and disposition nonconforming materials while ensuring appropriate risk assessments are completed and documented in accordance with established quality procedures.
- Support internal, customer, and regulatory audits by preparing quality records, presenting quality metrics, participating in audit responses, and ensuring timely closure of audit observations.
- Monitor and report key quality indicators including first pass yield, defect rates, customer complaints, CAPA effectiveness, supplier performance, and cost of poor quality to leadership and cross-functional stakeholders.
- Review supplier quality performance and participate in supplier investigations, supplier corrective action requests (SCARs), and supplier qualification activities as needed to ensure purchased materials meet quality requirements.
- Participate in risk management activities, including PFMEA reviews, risk assessments, and implementation of risk control measures to ensure patient safety and product effectiveness.
- Support customer interactions related to quality performance, investigations, corrective actions, and continuous improvement initiatives,



maintaining a strong focus on customer satisfaction and compliance.
- Drive a culture of quality excellence by proactively identifying risks, recommending process improvements, and promoting compliance with established quality management system requirements.

The experience we’re looking to add to our team:

- Advanced English
- Bachelor’s Degree
- Responsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products.
- Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
- Analyzes reports and returned products and recommends corrective action.
- Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilities.
- Approves product, process and equipment qualifications.
- Provides liaison to various regulatory bodies

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

- Pantry vouchers
- Saving Fund
- Christmas bonus
- Holiday bonus
- Medical Insurance
- Life Insurance

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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 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).

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📌 Quality Engineer (Medical Devices) (Tijuana)
🏢 Flex
📍 Tijuana