This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimum supervision. Under minimal supervision administer Device Master Record (DMR), Change Orders and quality records in accordance with corporate documentation procedures and FDA Good Manufacturing Practices (GMP). This includes administering the documentation aspects of engineering change management, responsibility for the accuracy and reliability of the document data bases, and the maintenance of hard copy and electronic DMR files. Provides training and technical support within the document center and to other user groups in the administration of the Product Lifecycle Management system.
PRIMARY RESPONSIBILITIES
BASIC QUALIFICATIONS
PREFERRED/DESIRED QUALIFICATIONS
• Bachelor’s Degree in Supply Chain, Manufacturing Systems, or Information Management is preferred
• 3-5 years of related experience in a business environment
• Intermediate to advanced knowledge of Microsoft Office applications (Outlook, Word, Excel, PowerPoint, Access)
• Proficient task management including prioritization skills
• Self-motivated, organized, details oriented, efficient and process oriented
• Team player
• Strong work ethic
• Works well under pressure in a dynamic environment
• Tactful, exercises independent judgment and discretion
• Professional presentation and strong interpersonal communications skills
• Strong judgment and time management skills
• Ability to independently write, review, and implement work instruction content to support new systems and processes.
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