Quality Assurance Core 1

2 weeks ago

Rocklin, United States JobRialto Full time

Job Description:This role provides engineering, design and integration support in a team specializing in the development of First-Of-A-Kind machinery for manufacturing and R&D as well as Application Engineering for E&I materials.Participate in projects/assignments that support continuous improvement efforts and department/company goals especially as they relate to translation projectsAssist in maintaining quality system documents.Review submitted document change requests to ensure all work and processes comply with established cGMP and other related standards. Provide feedback and request corrections as needed.Process documentation changes in document control system: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes accurately and in a timely manner while ensuring that they meet the department goals and objectives.Promptly respond to questions and issues raised by Originators and Approvers. Work with Originators in following up, analyzing and helping to resolve open change control issues.Process product labeling and instructions for use labeling for creation and updates. Implement labels per quality procedures.Maintain document control records upon completion, i.e., scanning, filing.May be required to perform additional administrative duties to support Quality organization i.e., filing, organizing, and cataloging records.Support Document Control department activities.Assist in training employees in Document Control processes, specifically translation processes.Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual.May be required to perform additional duties as assigned.Education: High SchoolAdditional client information:

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