Quality Engineer- Audit Readiness

4 weeks ago

Worcester, United States Azzur Group Full time

From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

Responsibilities:

  • Prepare and facilitate audit readiness by conducting comprehensive
    assessments and implementing necessary changes to address any identified
    issues, including updates to procedures, process enhancements, and corrective
    and preventive actions (CAPAs).
  • Collaborate with cross-functional teams to ensure all aspects of the quality
    management system are aligned with regulatory requirements and industry
    standards in preparation for audits.
  • Lead the execution of procedural updates, process improvements, and CAPAs to
    enhance the effectiveness and compliance of quality systems and processes.
  • Develop and implement strategies to proactively address potential audit findings,
    driving continuous improvement initiatives across the organization.
  • Analyze audit findings and identify root causes to develop robust corrective
    actions, fostering a culture of quality and compliance within the manufacturing
    environment.
  • Provide guidance and support to internal stakeholders on audit-related matters,
    including interpretation of regulations and standards, to ensure alignment with
    audit requirements.
  • Monitor and track progress on audit readiness activities, maintaining
    documentation and records to demonstrate compliance with regulatory
    expectations.
Requirements:
  • 4+years experience
  • Auditor Certification (nice to have)
  • Experience and working knowledge of FDA regulations/ISO standards for
    medical devices

#LR-KR1

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