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    Quality Management System Manager - Wayland, United States - Whitridge Associates

    Whitridge Associates
    Whitridge Associates Wayland, United States

    3 weeks ago

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    Description

    SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:


    Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

    Key opinion leader for the oversight over manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.

    Lead product and process improvement initiatives.
    Leads and maintains the development, completion, and maintenance of risk analyses.
    Supports the generation and completion of protocols and reports for product, process, and test method validations.
    Support the development implementation, and maintenance of defect categories.

    Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies.

    Lead the development of various inspection techniques and procedures to ensure product integrity to design specifications.

    Lead the disposition of non-conforming materials meet all necessary regulatory requirements, support the investigation process and assure adequacy of corrective actions to prevent re-occurrence.

    Conducts complaint investigations and remediation recommendations as needed.

    Lead CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.

    Conduct Supplier Audits and investigations as needed.
    Provide leadership and oversight for Supplier Qualifications process.
    Leads the product transfers process and the construction of any Device History Files.

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