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    Quality Engineer - Santa Clara, United States - Integrated Resources

    Integrated Resources
    Integrated Resources Santa Clara, United States

    3 weeks ago

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    Description

    The Equipment Calibration and PM Engineer will support the equipment maintenance and calibration programs at the Redwood City, Santa Clara, and San Jose site. They will ensure compliance of these programs, provide investigation and nonconformance support, and drive continuous improvement efforts. The position acts as a technical advisor on all equipment issues. Additional responsibilities may include performing process improvement projects. This position reports to the Equipment Calibration and PM Manager.

    Duties and Responsibilities:

    • Works directly with customers, engineering, manufacturing, and other groups to develop appropriate equipment specifications for calibration and preventative maintenance (PM), such as parameters, intervals, tolerances, acceptance criteria, and operating limits for new and existing equipment and systems.
    • Review all equipment specifications and records information for completeness and appropriateness.
    • Provides communication, direction, mentoring, training, and guidance for employees.
    • Review and approval of Calibration, PM, documents, and reports.
    • Manages service providers to ensure scheduling in accordance with Cal and PM due dates; coordinates the testing, monitoring, and inspecting processes of equipment calibration and PM.
    • Collect, report, and maintain calibration and preventive maintenance performance data into Computerized Maintenance Management System (CMMS).
    • Collaborates with multifunctional groups to resolve calibration/maintenance issues, support nonconformance investigations, improve equipment reliability, review procedures, and minimize equipment downtime.
    • Participates in product, project, and process development teams to provide quality support and mentorship.
    • Supports all audits.
    • Other related duties may be assigned.

    Qualifications

    Bachelor's Degree in Engineering or technical certifications in a related field is required.

    Required Skills and Experience:
    • Minimum 2 years of proven performance ability working as an Equipment Engineer or Sr. Equipment Technician in a high-volume manufacturing environment.
    • Experience in review & approval of specification of Calibration, Maintenance, and qualification documentation.
    • Able to analyze data, compile reports, and recommend corrective action.
    • Basic knowledge in the areas of Design Controls Processes, Equipment Validation, Manufacturing practices/principles, and statistical techniques.
    • Outstanding organization, communication, presentation, and interpersonal skills working within the organization.
    • Able to work independently, efficiently, and collaboratively with all levels of employees and management.
    • Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor.
    • Ability to travel and work at local sites (e.g. Redwood City, Santa Clara, and San Jose).

    Preferred Skills and Experience:

    • Experience working in the medical device field.
    • Certified ISO 9001/13485.
    • Experience with computerized management systems, such as SAP and CERDAAC or equivalent.
    • Solid understanding of 21 CFR 820, cGMP, GXP and good documentation practices.
    • Efficiency with Microsoft Office Products such as Word and Excel or equivalent software application.
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