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Bethel

    Quality Systems Engineer - Bethel, United States - Resonetics

    Resonetics
    Resonetics Bethel, United States

    1 week ago

    Default job background
    Permanent
    Description

    Overview:

    This position employs an individual skilled in advanced quality assurance techniques with an in-depth understand of the ISO 13485 Quality standard. Areas of focus include but are not limited to: statistical process control, performance metrics, customer management, ISO, FDA, and GMP compliance. This position will focus primarily on improving quality systems infrastructure in a contract manufacturing environment. Additionally, this individual will also be responsible for the maintenance and improvement of the Resonetics ISO certified Quality System. There will be a concentration on customer related and internal process related activities including surveys and audits.

    Responsibilities:

    Partner to establish, document and maintain all Quality Assurance policies

    and procedures across all Resonetics locations. This includes upkeep of the Resonetics Quality Manual and supporting procedures.

    • Liaising with customer quality personnel to resolve issues and customer complaints.
    • Partner with appropriate parties to resolve corrective and preventative actions.
    • Assist with customer and regulatory audits.
    • Take ownership of assigned production readiness activities to ensure that quality awareness is inherent in process development.
    • Develop and assist with development of standard operating procedures, including solicitation of functional department input and participation in process development.
    • Lead quality improvement initiatives across multiple sites and report on the progress.
    • Conduct weekly/monthly reporting of activities and key metrics.
    • Customer liaison for quality system related issues. May assume project manager role for specific customer applications.
    • Train Resonetics employees on quality principles and procedures.
    • Administer and improve Resonetics' quality management system, including its quality information systems.
    Qualifications:
    • Minimum 5 years' experience in a Quality Systems role.
    • Demonstrated background in an ISO 9001 or ISO 13485 or comparable quality and regulatory system.
    • Strong writing skills.
    • Bachelor's degree in a technical discipline or equivalent experience
    Compensation:

    $60,000-$80,000

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