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East Hanover

    Quality Systems Manager - East Hanover, United States - Synerfac

    Synerfac
    Synerfac East Hanover, United States

    2 weeks ago

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    Description

    Details:
    Our client in Fairfield, NJ is searching for an experienced Quality Systems Manager for their Medical Manufacturing Division.


    Job Description:

    • Oversee all aspects of the organization's quality system and improvement efforts
    • Developing, implementing, and administrating the program, training, and coaching employees
    • Responsible for establishing policies and procedures at all levels to ensure quality improvement efforts will meet or exceed internal and external customer needs and expectations
    • Responsible for dealing with customers and suppliers on quality or performance issues
    • Responsible to facilitate management review meetings and report on the performance of the quality system and its metrics
    • Manage Internal Corrective Actions (ICAR) and verify effectiveness of corrective actions through auditing
    • Responsible for the maintenance of the Master Databases on the company network
    • Maintains and controls the company ISO13485 / 21CFR820 Training records for all company team members
    Job Requirements


    Details:

    Job Requirements:

    • 5 years or more experience in Quality Control/Assurance in a tight tolerance industry with a medical device or life sciences customer base
    • Thorough understanding of automotive and medical industry quality requirements (APQP, FMEA, Process Flows, Control Plans, Measurement System Analysis)
    • Certified Lead Auditor responsible for the company internal audit program in compliance with ISO13485 / 21CFR820


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