Quality Engineer- Audit Readiness

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 experienceAuditor Certification (nice to have)Experience and working knowledge of FDA regulations/ISO standards for medical devices

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