Documentation Control Support Specialist

AGA Medical Corporation, a medical technology company, is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.As a Document Control Support Specialist, you will maintain and operate the established documentation control/configuration management system at AGA Medical Corporation. This includes electronic documentation control implementation/maintenance and providing necessary input/maintenance of product configuration database for AGA business system. Provide necessary support to ensure proper creation, coordination, filing management, storage, and retrieval of all controlled engineering and quality system documentation. Set-up and maintain on line accessibility and status accounting of all controlled engineering and quality system documentation. Create and maintain configuration Item Master List and BOM’s using business system software as required. This includes consulting with “change order” originators and engineering personnel to determine requirements for and appropriate Item Master/BOM information based on engineering drawings and other product data. Maintain established product configuration identification system including part numbering, naming, nomenclature etc. Train appropriate AGA personnel on aspects of the documentation control system as required. Serve as documentation coordinator, and provide support for the configuration management (CM)/ Change Order (ECO/DCO) system, including word-processing as needed. Familiarity with CAD and Solidworks software systems and understanding engineering drawings as required/related to Engineering Change Orders. Maintain currency of related database through ILI. Assure that documentation conforms to appropriate Regulatory, QSR, MDD and ISO/EN guidelines. Participate in providing document/data records as required to satisfy internal and external audits. Provide support in general word processing, slide/overhead presentations, and documentation graphics (flow charts, simple diagrams, etc.) as requested by department manager. Interface with all department levels of the company. Qualifications: Bachelors degree in a related area preferred. Two or more years experience in documentation control in a medical device manufacturing or similar environment. Computer literate with expertise in MS Word (Access, Excel and PowerPoint a plus). Able to read and interpret engineering drawings; and harmonize information with related technical documentation/specifications. Strong technical writing/editing skills. Documentation Change Order (ECO/DCO) experience. Familiarity with AutoCAD and Solidworks systems preferred. Electronic training management system experience preferred. Business system/MRP experience (e.g. Fourth Shift, JD Edwards, AS400) preferred. Knowledge of or familiarity with ISO 9000 Documentation and Records Control requirements. Detail oriented, self-motivated, and able to handle multiple tasks in a fast paced, multifaceted environment. -For quick consideration apply here We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more. An Equal Opportunity/ Affirmative Action Employer Please, No Agencies Position Information Location: Plymouth, MN Job Category: Quality Assurance/Safety Contact Information reference code: 1160