Document Control and Change Analyst Engineer
Document Control Engineer
Responsible for controlling and maintaining the engineering change and documentation tracking process with emphasis on Bills of Material (BOM’s), specifications, drawings and documentation to ensure appropriate changes are documented.
Implements and finalizes engineering change orders (ECO's) and makes system changes.
Ensures projects are in compliance with document control policies and procedures.
Ensures data accuracy and completeness of documentation including logs, reports and distribution.
Responsible for interface between customer focus team and supporting function to ensure appropriate changes are documented, document released in FlexQ or process through Document Control released.
Document Manager for FlexQ QDM module.
Ensure procedures, instructions and forms compliant to site documentation requirement.
Responsible for controlling and maintaining the engineering change and documentation tracking process with emphasis on Bills of Material (BOM’s), parts masters, specifications, drawings and documentation to ensure appropriate changes are documented
Coordinates ECO status with engineering and program management team to implements effective dates.
Ensures projects are in compliance with document control policies and procedures for any engineering change..
Ensures data accuracy and completeness of changes documentation including logs, reports and distribution.
Manages and tracks product configuration and manufacturing/customer requirements change through the change control
Assists in the review and design of process changes for completeness, accuracy and compliance to the FDA Quality System Regulation, and ISO 13485 Standard
Responsible for interface between program management, engineering, manufacturing and materials to ensure appropriate changes are documented.
Performs frequent audit of the change request to ensure it’s proper implementation.
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