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    Supplier Quality Engineer - South Plainfield, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences South Plainfield, United States

    3 weeks ago

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    Description
    Roles and Responsibilities:
    1. Collaborate with cross-functional teams to establish quality and performance metrics for suppliers.
    2. Establish regular connects with supplier to evaluate Material changes to Parts/Components and decide the implementation actions.
    3. Monitor and track supplier performance and provide regular reports to management.
    4. Develop and maintain strong relationships with suppliers to ensure effective communication and alignment on quality expectations.
    5. Ensure compliance with all applicable regulatory requirements and company quality standards.
    6. Represent the company in supplier quality-related meetings and discussions.
    7. Proactively identify potential risks and implement risk mitigation strategies.
    8. Act as a subject matter expert on supplier quality and provide guidance and support to other departments as needed.
    9. Manage Supplier Change Requests and changes relating to supplier improvement initiatives
    10. Support supplier quality teams, to establish the processes for: Delivering quality parts, materials, and services, preventing defects.
    11. Participate in supplier selection processes to ensure quality requirements are met.
    12. Develop and maintain quality standards for suppliers in accordance with industry regulations and company policies.
    13. Evaluate and qualify new suppliers through audits and assessments to ensure their capability to meet quality requirements.
    14. Excellent organization, Planning, Computer skills, technical writing, Communication skills. MS Office Suite and Outlook.
    Must Have:

    Minimum of 4 years of relevant experience in Engineering and/or Quality or advanced degree in Engineering, Science, or technical field

    Nice to Have:

    1. Audit Training (ISO 13485 and FDA 21CFR820Training)
    2. PLM Tools: AgileMap, Windchill, SAP
    3. PowerBI
    4. ASQ CSQP and/or CQE Certificate
    5. CAPA Training
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