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    Quality Engineer - Irvine, United States - Cypress HCM

    Cypress HCM
    Cypress HCM Irvine, United States

    3 weeks ago

    Cypress HCM background
    Description

    Quality Engineer II

    How You'll Make An Impact:

    • Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports including:
    • Analysis of post market data and reviewing completed reports with business partners.
    • Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
    • Maintain, archive and completed controlled quality records.
    • Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
    • Facilitate and/or chair local/regional PMS Board meetings.
    • Support various QMS and PMS projects (local and global) as needed.
    • Support internal/external audits as needed.
    • Perform other related duties and assignments as needed.

    What You Bring:

    • Bachelor's degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.
    • Experience in a regulated manufacturing industry or equivalent combination of education and experience.
    • Understanding of GMP and quality system standards as they apply to products manufactured.
    • Understanding of product post market surveillance requirements for IVD products a plus.
    • Working knowledge of device/drug/biotech manufacturing processes.
    • Detail-oriented and ability to multitask.
    • Problem solving, decision making, time management, organization, communication, leadership, and computer skills.
    • Advanced technical writing and word processing skills.
    • Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus

    Up to $52/hour DOE

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