job summary

to support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a quality engineer located in juarez sur.

reporting to the director quality , 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:

- intermediate 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

em57

job category

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 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 (Chihuahua)
🏢 Flex
📍 Chihuahua