Description
Essential responsibilities and duties include, but are not limited to the following:- Plans, develops, implements, and maintains the document control system as required by FDA and ISO for medical devices.
- Processes document control required by various departments within regulatory guidelines, objectives and due dates set by QA Manager.
- Maintains Device Master Record and Design History Files. Maintains all documentation in an organized fashion.
- Ensures all documents and specifications used in the procurement of raw materials and in the manufacture of company's products are current and accurate and that any changes made to those documents are in compliance with established procedures for Change control of documents.
- Ensures that all changes to specifications and procedures are documented in compliance with FDA and ISO regulatory guidelines.
- Uses AutoCAD and Solidworks software for drafting and drawings.
- Establishes and maintains Design History Records as required by the Design Control procedures.
- Establishes and maintains current standard files.
- Organizes and maintains all engineering studies, verification and validation reports.
- Establishes and maintains any required clinical study files.
- Establishes and maintains regulatory files associated with new product filings.
Job Qualifications and Education:
- Bachelor's degree (B.A.) from four-year college or university
Must have:
- Experience as a document controller in a medical device environment (+5 years).
- Excellent file maintenance skills and experience with maintenance of Device Master Records and Design History Files.
- Experience in the regulatory requirements of FDA and ISO for control of documentation.
- Strong computing and data-base management skills. MS Office specifically MS Access.
- AutoCAD and Solidworks for drafting/drawings.
- The ability to work independently.
- Excellent organization skills and be detail-oriented.
To find out more about Real please visit www.realstaffing.com