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    Supplier Quality Engineer - Boston, United States - INTELLECTT INC

    INTELLECTT INC
    INTELLECTT INC Boston, United States

    1 week ago

    Intellectt Inc background
    Description

    Job Title:
    Supplier Quality Engineer

    Location:

    MA

    Key Responsibilities:

    Quality Standards:

    This role requires you to establish and maintain supplier quality standards, ensuring they align with industry regulations and the company's internal requirements.

    This could involve creating detailed specifications and inspection criteria and regularly updating them as needed.

    Supplier Performance:
    You will be monitoring key performance metrics for suppliers, including defect rates, on-time delivery, and overall quality improvements. This also involves reporting on these metrics to stakeholders within the organization.

    Root Cause Analysis:
    A significant part of this role is conducting root cause analyses for quality issues and non-conformances.

    You'll need to work closely with suppliers to identify the underlying causes of these issues and drive corrective and preventive actions.


    Quality Improvement:

    As a consultant, you will lead initiatives to improve quality processes, working with suppliers to implement process changes and continuous improvement plans.

    This might involve introducing new quality control methods or collaborating on quality-focused projects.

    Regulatory Compliance:

    Given that this role is in the medical device industry, you need to ensure that suppliers comply with all relevant regulations and industry standards, including FDA QSRs, ISO13485, and others.

    This also involves staying updated with regulatory changes and advising suppliers accordingly.

    Risk Management:
    Identifying and mitigating risks related to supplier quality is critical. This could involve risk assessments, contingency planning, and addressing potential supply chain disruptions.
    Cross-functional Collaboration: The role requires close collaboration with other internal departments, such as procurement, engineering, manufacturing, and quality assurance. Effective communication and teamwork are essential.

    Documentation:

    Maintaining accurate and comprehensive records of all supplier quality activities, including audits and quality agreements, is part of the role's responsibilities.

    Job Qualifications

    Educational Background:
    A bachelor's degree in an engineering discipline is required, providing a technical foundation for the role.

    Experience:
    The ideal candidate has 7-10+ years of experience in Supplier Quality within the medical device industry. Experience with complex products, especially in catheter-based or cardiac assist devices, is preferred.
    Quality Control
    Experience:
    You should have experience with formal problem-solving methodologies, deductive skills, and handling non-conforming materials or assemblies.

    Regulatory Knowledge:
    A solid understanding of FDA QSRs, ISO13485, Ordinance 169, ISO14971, and similar regulations is essential.

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