Identifying and managing all controlled documentation to ensure compliance with operational, corporate and regulatory requirements. Providing effective and efficient documentation and records management. Coordinating the scheduling of formal document reviews for site documentation. Maintains file system of the current drawing revisions and documents of external origins Communicating changes to document control procedures or other relevant information which have been updated or added. Disposing or destroying records and documents in a secure and proper way when retention periods expire. Scan and enter material certifications and SDS into the system Support Customer and Regulatory audits by pulling required documentation Prepare work orders for production team and verify that all required documentation is attached Read blueprints, data, manuals, or other materials to determine specifications, inspection, and testing procedures, adjustment methods, certification processes, or measurement instruments required for work orders Measure and document core/mandrel dimensional readings for lot release. Review and approve inspection results and device history records for completeness Create the Certificate of Conformance and all customer requirements for shipping Reading and interpreting manufacturing procedures, engineering drawings, customer specifications and inspection procedures and comply with their requirements Understand Good Documentation Practices Assist in the investigation, control and disposition of nonconforming materials Interact with customer and supplier material compliance activities Maintain data files, training and competency records. Analyze and trend quality metrics to identify opportunities for improvement and participate in continuous improvement projects Identify, facilitate, and perform all necessary measures of the Quality Management System as directed by the Quality Manager Perform calibrations and schedule outside metrology services Assist with daily yield collection and maintain monthly spreadsheets Other responsibilities may be assigned as required
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Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED