Duties:

• The QA Associate Quality 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 nonconformance 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.