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

    Whitridge Associates
    Whitridge Associates Wayland, United States

    6 days ago

    Default job background
    Upper Management / Consulting
    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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