Quality Engineer I

Title : Associate Quality Assurance Engineer

Location : Johns Creek GA

Duration : 24+ Months

Pay Range : $30 / hr - $34 / hr

• The Associate QA Engineer will lead activities involving product impact assessments, product quarantine, non-conformance reporting / issue resolution, auditing of production areas, and procedural updates to ensure the process and documentation to 21CFR820, ISO and internal requirements.
• Actively participates in Production Triage team as the lead Quality member by providing direction and support to the non-conformance process, product quarantine as non-conformance arise.
• Ensure non-conformance reports are initiated per established requirements and applicable activities are identified and implemented.
• Responsible for performing Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing / dispositioning non-conformance records for quarantine release and removal of product from quarantine area.
• Audits personnel and processes in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.).
• Analyze audit results for trends and provide feedback to QA OP s Management and QA team.
• Initiates and leads QA Operations process improvement projects from developing the business case through to implementation including creating / revising procedures using the Change Control process.
• Conducts failure investigation to analyze internal system or process failures and implement preventive and corrective action. Uses various statistical and non-statistical problem-solving tools as part of analysis.
• Bachelor s degree in Engineering Required