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Supplier Quality Engineer

Katalyst Healthcares & Life Sciences

  • Bedford, MA
  • 9 days ago

    Highlights

    Roles and Responsibilities: Responsible for achieving a state of high-quality performance at our Supplier partners through the application and practice of Advanced Product Quality Planning 'APQP', Supplier Qualification (Audit, Quality Agreement/Change Notice Agreement), and continuous monitoring the performance supplier to drive zero defect through Supplier Corrective Actions and notification. Providing Quality oversight of product/process change requests from suppliers (SICRs: Supplier Initiated Chage Requests), ensuring appropriate regulatory review and adequate validation to support requested changes including following our APQP process and leading process validation, as necessary.

    Numbers & Facts

    LocationBedford, MA

    Description

    Roles and Responsibilities:
    • Responsible for achieving a state of high-quality performance at our Supplier partners through the application and practice of Advanced Product Quality Planning 'APQP' , Supplier Qualification (Audit, Quality Agreement/Change Notice Agreement), and continuous monitoring the performance supplier to drive zero defect through Supplier Corrective Actions and notification.
    • You will fill a high-profile, cross functional position and play an integral role enabling development and production flow of Philips IGTD's critical supply base.
    • You will work in close coordination with Product Engineering, Supply Chain and Production and Suppliers to execute effective, creative and smart supply chain strategies to achieve production goals.
    • Perform Process Validation and Verification across Spectrawave IGTD portfolios for Consoles and Catheter parts.
    • Collaborate with R&D and Quality Design Assurance in Design for Manufacturability and Part Risk management per DFMAE and PFMEA.
    • Perform Process Validation , Verification, Test Method Validation, and assess CTS/CTQ criteria per APQP requirement for +700 parts.
    • Support Supplier Qualification including Audit, Quality Agreement and Change Notice Agreement.
    • Perform Problem solving in the case of FAI and APQP failure.
    • Deep dive Value Stream mapping across process.
    • Conducts thorough investigations of defects to determine if they are supplier-caused and implement corrections using the SCAR process.
    • Proactively manage, monitor, and troubleshoot supplier-related issues for quality of components, sub-assemblies, and assemblies includingmonitoring trends and managing Supplier Improvement and Supplier Quality Performance Monitoring.
    • Providing Quality oversight of product/process change requests from suppliers (SICRs: Supplier Initiated Chage Requests), ensuring appropriate regulatory review and adequate validation to support requested changes including following our APQP process and leading process validation, as necessary
    • Develop and oversee process validation plans, including equipment qualifications, with suppliers and lead continuous improvement projects based on process/product trends, customer complaints, industry standards, and government regulations.
    Education and Experience:
    • Bachelor's degree engineering (Master Degree is plus).
    • 3+ years of engineering experience (Manufacturing Engineer and/or Product Quality is plus).
    • In-depth product manufacturing and quality experience in process validation and verification Subject Matter in IQ, OQ, PQ
    • SO, 13485 Lead Auditor certified is plus.
    • Experienced in plastic, metal, electronics commodities.
    • Strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally and complete assignments with accuracy and a high attention to detail

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