Sally Eng Email & Phone Number

Experienced Document Control Analyst with a strong track record of managing product structures, maintaining BoM configurations, and overseeing Change Requests and Orders for engineering and manufacturing. Skilled in leveraging Agile PLM and ERP systems to ensure ISO and FDA regulations compliance. Proven ability to support audits, quality assurance, and new product introduction projects while administering training systems and facilitating cross-functional collaboration. Adept at managing complex documentation processes and driving continuous improvement initiatives in fast-paced, regulated environments

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  Document Control Specialist / Change Analyst

  Natus Medical Incorporated

  Jun 1991 - Present

  Provided support for product structure, troubleshooting, and implementation of products, parts, and BoM structure from the PLM system (Agile) and factory ERP system (EBusiness) for medical devices.• Processed Change Requests and Change Orders for Engineering & Manufacturing within factory client database. Managed all BoM configurations for all product families. Resulting in a reduction packaging errors.• Executed quality assurance for change control documents such as engineering drawings, standard operating procedures, inspection procedures, assembly procedures, specifications, tools, and forms.• Key team member on New Product Introduction projects and continuance engineering projects.• Responsible for managing the duties and resources required to support document maintenance and change activities, as required by ISO and FDA regulations• Hosted all FDA audits, internal audits, product structure, and manufacturing issues. Allowing for high compliance. • Key support member on special projects as needed.• Contributed to the successful implementation of an electronic scanning and filing system.• Supported CRB meetings by using the Agile PLM system.• Maintained and reviewed all Work Order (WO)/Design History Record (DHR) packets for completeness and good documentation practices. Resulting in a good quality product.• Generated metrics on WO/DHR quality and Design Change Order (DCO)/Engineering Change Order (ECO) processing.• Supported quality system training files as per duties of training system administrator to be compliant as required by the regulation

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  University Of Santo Tomas

  Food Technology And Processing