Senior Quality Assurance Engineer - Los Angeles, United States - BioTalent

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    About the job
    General Description

    This position must has significant experience and also display strong leadership capabilities. This position is a QMS subject matter expert.

    Job Knowledge And Duties

    Open, investigate, and close NCRs
    Open, investigate, and close complaints
    Create metric reports as assigned
    SPC Monitoring
    Participate in CAPA Projects
    Participate in validation & measurement capability projects
    Update procedures as required
    Identify and perform continuous improvement projects
    Product line ownership
    Execute validations
    Create control plans and PFMEAs
    Perform Internal Audit
    Perform Supplier Qualification and audits
    Customer facing role, run Drumbeat customer meetings
    Leadership role, direct reports of Inspectors or Technician
    Owner of critical Quality Subsystems
    Act as SME in regulatory inspections

    Education, Experience, Skills, And Knowledge

    4 Year Degree or equivalent experience
    Minimum years' experience
    Proficient with math, statistics, and reading comprehension
    Proficient with computer skills (Microsoft Office, etc.)
    Basic understanding of QMS
    Working knowledge of Excel and database programs
    Solid understanding of Quality System Regulations (complaint, NCR, containment, root cause, etc.)
    Functional Quality statistical knowledge (AQL, sampling, etc.)
    Proficient with QMS
    Strong leadership abilities
    Capable of independent project management

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