Supports the development, implementation and maintenance of quality assurance systems and activities at MNL. Specifically, coordinates and manages the Engineering Change Order process and all associated documentation used in Good Manufacturing Practices and audits production and Quality Control areas as needed. Manages the PDM and MRP systems reproducing engineering/manufacturing documentation, such as drawings, bills of materials, parts lists specifications and engineering change orders. Ensures that master drawing files and history files are accurate and current, and that effective control is maintained over drawings and other document records. Required to keep documentation for external regulations or procedural guidelines such as FDA, ISO-9000 standards, or HIPAA. In addition, supports the internal audit, CAPA, quality system training, and quality metric reporting system at MNL. 

Position Responsibilities

* Follow and insure that personnel follow good Manufacturing Practices and SOP’s as defined by Medtronic Navigation’s policies, practices and procedures to insure that Food and Drug Administration and ISO/MDD regulations, Medtronic and other applicable standards are met.* Manage the daily activities of MNL Document Control including working with engineering to ensure timely and accurate implementation of ECO’s.* Coordinate changes within the Product Data Management systems and ERP systems. * Support the MNL Internal Audit Program.* Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. * Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. * Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. * Supports the administrative aspects of the MNL CAPA system. * Conducts training on the MNL Quality System as requested.* Works on projects to maintain and improve the MNL Quality System.* Maintains and support quality metric reporting at MNL* Perform other duties as assigned. 

Basic Qualifications

* Associate’s degree in a science related or computer technology area.* Previous Quality System experience (3yr)* Document Control knowledge (3yr)* Quality System/Document Control understanding and knowledge.* Demonstrated ability to complete assignments of increasing complexity.* Good understanding and working knowledge of computer databases and systems.* Knowledge of ERP systems (SAP, Oracle, or equivalent) 

Desired/Preferred Qualifications

PREFERRED EDUCATION and/or EXPERIENCE:* Bachelor’s Degree in Science or a related field.* Knowledge of Manufacturing software, e.g. JDE, SAP.* Knowledge of data management products, e.g. Omnify, MatrixOne, Agile, etc)* Microsoft Office Suite. 

Physical Job Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to stand, walk, lift, and reach with hands and arms. Specific vision abilities required by this job include normal vision.

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