Senior Quality Engineer

New Today

Responsibilities: Provide training and collaborate with the transitioning employee to ensure knowledge transfer. Support the implementation of the Process Operations Management System (POMS) and Electronic Batch Records (EBR). Focus on documentation tasks, including batch records and CAPAs, rather than direct floor work. Manage CAPA (Corrective and Preventive Actions) processes effectively. Review and ensure completeness of quality-related events. Conduct review and approval processes for quality documentation. Oversee calibration activities as part of quality assurance. Provide quality approvals in compliance with industry standards. Update procedural Business Operating Procedures (BOPs) as needed. Assist in validation processes where required. Utilize Maximo for quality-related activities. Requirements: Senior-level experience in Quality Engineering within a regulated industry. Strong understanding of documentation practices, including batch records and CAPA management. Ability to work independently and integrate quickly into existing teams and processes. Familiarity with quality management systems, including review and approval workflows. Hands-on experience with Maximo or similar asset management software. Proficiency in procedural updates and compliance documentation. Experience with validation processes in a manufacturing or product development environment. Strong problem-solving and analytical skills.
Location:
Waukegan

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