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    Sr. Supplier Quality Engineer - Santa Clara, United States - Shockwave Medical

    Shockwave Medical
    Shockwave Medical Santa Clara, United States

    6 days ago

    Default job background
    Description
    Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

    Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

    Position Overview
    The Sr.

    Supplier Quality Engineer performs work with general supervision to provide and implement solutions to broad problems and accomplishes complex assignments.

    The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues. The Sr.

    Supplier Quality Engineer participates in decisions related to scope of work, risk management, process improvements, material disposition, and the implementation of revised product specifications.

    Essential Job Functions
    Partner with Procurement, R&D, Operations, Quality, and Suppliers in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations
    Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to the next management level
    Plan, schedule, execute, report, and follow-up on supplier audits
    Initiate, issue, review, and approve Supplier Corrective Action Reports (SCARs)
    Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions
    Own, manage, and drive to completion Supplier Change Assessments (SCAs)
    Participate in component qualification change projects in collaboration with key business partners and the supplier's applicable functional groups
    Compile, analyze, and summarize supplier performance data for periodic management reviews
    Manufacturing Support
    Review, investigate, disposition, and drive to completion Non-conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs)
    Initiate, review, and approve Document Change Orders (DCOs)
    Provide technical support and guidance to the Quality Assurance group
    Support internal and third-party audits (FDA, Notified Body)
    Participate in Material Review Board (MRB) meetings
    Manufacturing Line Transfers
    Partner with cross-functional teams to define requirements and generate documentation for the transfer of manufacturing lines to Contract Manufacturers (CMs)
    Plan and provide on-site and off-site training to CMs on product inspection and testing
    Act as the primary Quality point of contact with CMs, and provide remote and off-site support on matters related to Quality
    Other duties as assigned
    Requirements
    BS degree in a related engineering discipline and 5+ years of relevant experience, or MS degree in a related engineering discipline and 3+ years of relevant experience
    Experience in the medical device industry is strongly preferred
    Strong understanding of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems
    Strong technical writing skills
    Effective communication skills across all levels of the organization
    Must be proactive, self-motivated, and able to work independently with minimal supervision
    Ability to work independently in a fast-paced environment while managing multiple priorities
    Experience in statistics (hypothesis testing, capability analysis, DOE, MSA, Gage R&R), Six Sigma, Lean
    Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus
    Able to lift objects weighing up to 25 lbs
    Ability to travel up to 20% of the time

    Market Range:
    $113,000 - $135,000
    Exact compensation may vary based on skills, experience, and location
    Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks -Core Benefits:

    Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

    Perks:
    ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

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