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    Compliance Engineer - Round Lake, United States - Stefanini

    Stefanini
    Stefanini Round Lake, United States

    3 weeks ago

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    Description

    Stefanini Group is hiring

    Stefanini is looking for Compliance Engineer in Round Lake, IL

    For quick Apply, please reach out to Nitin Kumar Chandila - call: / email:

    Work Hours: M-F (40 hours)

    Work Location: Round Lake, IL

    Shift: 1st Shift

    Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System. Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements. Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required.

    Responsibilities:

  • Work with internal auditors to develop programs to ensure continued compliance with policies and regulations.
  • Support internal audit process ensuring compliance with all applicable regulations and standards.
  • Evaluate quality data and determine strategies, actions, and initiatives to drive improvements in the facility. Work with cross functional teams on implementation.
  • Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.
  • Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure.
  • Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes.
  • Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective.
  • Candidates cannot be allergic to Penicillin or Cephalosporins.

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