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Fremont

    Senior Quality Engineer - Fremont, United States - Viant Medical

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    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
    We offer market competitive compensation. Potential salary range for this role is $110,000 - $125,000.Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law


    Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices.

    We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence.

    With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources.

    For more information, visit or follow us on LinkedIn.

    Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.

    Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

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