Responsibilities
- Manage the Admin Electronic Document Control tasks
- Maintain records of all controlled documents
- Issue part numbers, maintain BOMs and revision in the company’s business information system
- Maintain quality records as defined in procedures
- Manage ECO approval and the issuance process
- Maintain labels and manuals and update, as necessary
- Create detailed drawings and 3D models for medical device components and assemblies using SolidWorks.
- Collaborate with cross-functional teams including engineering, quality assurance, and manufacturing to gather
information for accurate specifications and documentation
- Support Internal and External audits
- Manage departmental staff if necessary
- Perform other duties as assigned
- Adhere to Exergen’s policies.
Salary commentate with experience.
Qualifications
- High school or college degree
- Five + years of document control or related experience
- 5+ years of Solidworks experience, preferably in a medical device manufacturing environment
- Experience with Electronic Document Platforms necessary
- Strong understanding of drafting and standard dimensioning practices. GD&T is a plus.
- Solid understanding of engineering document management, revision control and archiving process.
- Knowledge of regulated industry’s environment
- Experience with Adobe Illustrator and InDesign Software
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