Job Description

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

• Will administer the DMR, Specifications, Change Orders, Parts and Bills of Material, through the release and distribution processes in accordance with corporate and department documentation procedures and guidelines.
• Will interface with document creators and reviewers to evaluate and judge accuracy and completeness of DMR documentation and change paper within corporate procedure and GMP requirements.
• Will collaborate with other departments (e.g., design engineering, purchasing, quality, product line support, test engineering, and manufacturing engineering) to ensure necessary requirements will be met for documentation, parts and Bills of Material.
• Will provide training and support to team members and stakeholders on PLM and ERP tools.
• Will administer current and historical DMR files in accordance with defined filing standards, record retention policies and GMP.
• Will support configuration Management process improvement projects and Kaizens.
• Will help establish, create, and maintain document center guidelines and procedures.
• Will support and enforce data governance policies and procedures to ensure data accuracy, consistency, and compliance with regulations.
• Will train users on various systems and processes as needed such as technical support to customers and other department staff in DMR documents and processes in accordance with corporate document procedures and GMP, and in the use of the PLM and change system.
• May execute process and technology projects to add/correct/update/maintain required attributes for production, regulatory (UDI, ACE, PMA, MDD etc.), and to product master data tables to support Order to Cash process.

BASIC QUALIFICATIONS

• Bachelor’s Degree is required
• 3-5 years’ experience in configuration control, or 5 years’ experience with a combination of a minimum of 3 years’ configuration control experience and equivalent production experience

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

• Good written and oral communication skills

• 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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