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 Quality Engineer (Medical Devices) located in 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
Quality
Required 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. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email [email protected] 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).
