Quality Engineer

hace 7 días

Ciudad de México, Ciudad de México AMETEK A tiempo completo

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

  • Quality Engineer

    hace 4 días

    Ciudad de México, Ciudad de México AMETEK A tiempo completo

    The Quality Engineer is responsible for ensuring the effectiveness of internal activities related to incoming inspection, process control, and quality assurance for products shipped to our customers. This role involves planning, implementing, and coordinating prevention, control, and quality assurance activities to meet the quality expectations of both our...

  • Quality Engineer

    hace 7 días

    Ciudad de México, Ciudad de México Flex A tiempo completo

    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...

  • Quality Engineer

    hace 7 días

    Ciudad de México, Ciudad de México Flex A tiempo completo

    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...

  • Quality Engineer

    hace 4 días

    Ciudad de México, Ciudad de México Flex A tiempo completo

    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...

  • Quality

    hace 7 días

    Ciudad de México, Ciudad de México Capgemini A tiempo completo

    Descripción breve Jr - PMO Quality - At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the...

  • Quality Assurance Engineer

    hace 2 semanas

    Ciudad de México, Ciudad de México Sutherland A tiempo completo

    Interested suitable candidates please be in touch with Android Automation test engineer positionexp level 6-15 YrsKey Skill: Android automation test engineer with exp in Kotlin or Java and EspressoDetailed JD:Senior Android Automation Engineer, Quality Engineering MEXICOThe Difference You Will Make:Be a leader in leveraging AI to redefine and accelerate...

  • Supplier Quality Engineer

    hace 7 días

    Ciudad de México, Ciudad de México Flex A tiempo completo

    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...

  • Quality Engineer

    hace 4 días

    Ciudad de México, Ciudad de México Gentherm A tiempo completo

    Your Career. Your Impact. Your Future.  At Gentherm, we believe the next big breakthrough begins with you. As a global leader in thermal management and pneumatic comfort technologies, we develop advanced systems that deliver meaningful solutions to enhance health, wellness, comfort, and efficiency in everyday life. Our products and innovations are created...

  • Quality Engineer

    hace 7 días

    Ciudad de México, Ciudad de México Flex A tiempo completo

    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...

  • Quality Engineer

    hace 4 días

    Ciudad de México, Ciudad de México DiDi Global A tiempo completo

    Company OverviewDiDi Global Inc. is the world's leading mobility technology platform. It offers a wide range of app-based services across markets including Asia-Pacific, Latin America and Africa, including ride hailing, taxi hailing, chauffeur, hitch and other forms of shared mobility as well as auto solutions, food delivery, intra-city freight, and...