Description

• Editing and preparing new/revised Design History Files and Design Control Documents that are submitted for the design control process.
• Write protocols, execute validations, understand regulations, and make decisions
• Go into validation packages and strengthen them, rational, re-execution, process to process, site to site
• Redlines and Incorporates Assembly Procedure word files as required
• Creates and Updates device configuration control documents as necessary
• Interacts with related departments as necessary to ensure that redlined changes are implemented accurately including ensuring required training
• Establishes change orders and prepares for change authorization and documentation
• Reviews and analyzes released engineering change data and coordinates changes with engineering, quality, manufacturing
• Provides electronic storage for records retention to create images of documents and records. Indexes and organizes records based on standardized cross-filing system which can be retrieved in a timely manner
• Monitors record retention of all documents and coordinates records retrieval from electronic and physical storages as requested

Bachelors Degree in Biomedical Engineering, Pharmacists, Chemical engineering, or related field.