Job Title: Quality Engineer
Nuevo Laredo, MX, 88285
This is a professional position with responsibilities for elements of the quality program. The Quality Engineer is responsible for ensuring product and process quality throughout the manufacturing cycle, with a strong focus on ISO 13485:2016 compliance, incoming material inspections, equipment validation, and continuous improvement. This role supports internal audits, root cause analysis, and the implementation of corrective and preventive actions. The engineer will work closely with cross-functional teams to maintain high standards of quality and productivity. The quality engineer also serves as a technical reference and subject matter expert for colleagues with less experience.
Responsibilities - (Responsible activities)
- Apply and enforce ISO 13485:2016 quality standards across manufacturing processes, incoming materials, and final inspections.
- Conduct and document First Article Inspections (FAI) and ensure compliance with customer and internal specifications. Part inspection, including layout, in process, final, and receiving, using all types of mechanical inspection.
- Conduct Equipment Validation using IQ/OQ/PQ Methodology by writing and developing Protocol Validations.
- Develop and maintain work instructions, quality procedures, and inspection documentation. Support to translate documents from English to Spanish.
- Lead and support internal audits and assist in external audit readiness.
- Perform root cause analysis and implement corrective/preventive actions (CAPA).
- Monitor and improve key quality metrics such as yield, scrap, and customer returns.
- Support Engineering Change Orders (ECOs) and product validation processes.
- Support Engineering and Purchasing with historical supplier performance data for evaluation/selection of new products
- Collaborate with production, engineering, and supply chain teams to resolve quality issues.
- Maintain calibration systems for measurement and test equipment.
- Utilize ERP systems (AS400/INFOR) for quality documentation and inventory control.
Education - (Scholar Degree)
- Bachelor’s degree in industrial engineering, electronic, electrical or mechatronic.
- Knowledge of medical device regulations/standards, including 21 CFR 820 (QSR) and ISO – 13485:2016
Experience - (Years of experience)
- Minimum 1 year in a quality role within an electronics/medical manufacturing environment.
- Experience working in a Class I and Class II Medical Device environment
- Experience with incoming material inspection, FAI, and shipping quality control.
Background - (Hard Skills, Trainings, or required certifications)
- Proficient in Microsoft Office (Excel, Word, PowerPoint).
- Experience with ERP systems (AS400/INFOR preferable).
- English proficiency and ability to travel to the U.S. if required
Competencies - (Soft Skills)
- Critical thinker with good trouble shooting skills.
- Manage several projects concurrently and ability to show results