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East Hanover

    Quality Systems Manager - East Hanover, United States - Synerfac

    Synerfac
    Synerfac East Hanover, United States

    2 hours ago

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    Description

    Quality Systems Manager Needed in Fairfield, NJ

    Our client in Fairfield, New Jersey is in need of a skilled Quality Systems Manager for their Medical Manufacturing Division. This role is crucial in ensuring the organization's quality standards are met and continually improved.

    Job Description:

    • Oversee all facets of the quality system and enhancement initiatives
    • Develop, execute, and manage the program, providing training and guidance to staff
    • Establish policies and procedures across all levels to guarantee quality enhancement efforts meet or surpass both internal and external customer requirements
    • Address customer and supplier concerns related to quality or performance
    • Conduct management review meetings and deliver insights on the quality system's performance and metrics
    • Handle Internal Corrective Actions (ICAR) and assess the efficiency of corrective measures through audits
    • Maintain the Master Databases on the company network
    • Manage the company's ISO13485 / 21CFR820 Training records for all staff members

    Job Requirements:

    • 5+ years of experience in Quality Control/Assurance within a high precision industry servicing medical device or life sciences clients
    • Thorough comprehension of quality demands in the automotive and medical sectors (APQP, FMEA, Process Flows, Control Plans, Measurement System Analysis)
    • Certified Lead Auditor overseeing the internal audit program aligning with ISO13485 / 21CFR820 standards


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