Associate, Quality Systems

In this role, you will provide quality operations support through internal customer engagement. Lead and support continuous improvement for product and processes. Support plant functional areas such as engineering, operations, and maintenance by conducting data and document review/approval as it pertains to investigations and change management. Essential Duties and Responsibilities: 1. Review Issue Bracketing based on issue documentation, process knowledge, and available control strategies, revising the bracket as necessary. 2. Identify acceptable remediation activities for issues based on the issue documentation, investigations, and process capabilities. 3. Perform Risk Assessment to support remediation justification. 4. Use Trending, RCA, and Change Management tools to drive issue reduction activities. 5. Use all necessary quality systems in compliance with system and procedural requirements. 6. Interact with internal and external clients as needed. 7. Meet individual and departmental goals as required. 8. Understand and apply applicable FDA and ISO regulations/standards to the plant quality system.