Qualifications:

• Bachelor’s degree in Science or Engineering from an accredited college or university.
• Working knowledge of Documentation Change Management Process in a Medical Environment.
• Agile Document Repository and Change Management process.
• Microsoft Project.
• Ability to read technical specifications, drawings, and understand labeling standards.
• Knowledge of plant quality requirements as to on market product.
• Communication skills with internal and external suppliers and Client management.
• Ease of interpersonal relationships, communication skills and methodical problem solving.
• Minimum of 3 years in the manufacture of medical devices industry or combination of medical device or pharmaceutical industry.

Responsibilities:

• This includes writing and executing several Design Development Plans and project plan schedules for each product family to be changed.
• Overseeing Artwork Change and verification that it is correct for each List Number involved in the name change.
• Redling Artwork and Packaging Component Specifications for revised changes.
• Progressing these changes through our Agile Change Management structure.
• Working with the Supplier Change Notification process and Supplier Quality in any artwork name changes associated with purchased finished components where the Smiths Medical name needs to be changed to the Client Medical name.
• Working with R&D, Quality, Regulatory, Design Assessors and Plant Engineering to implement these name changes for all levels of packaging into production.
• Preparing and executing Change Management documentation to include Purchasing Specs, Artwork drawings and updating Bill of Materials.
• Ensuring smooth transition in artwork changes to replace the name Smith Medical to Client as needed to ensure continuity of documentation specs, IFU materials, and packaging materials.
• Communication with management to provide updates on project status and or contingency plans to ensure continuity of supply of materials used for on-market product and third party contracted product.
• Coordinate with Client groups to prepare and execute DDP (Design Development Pan) and any associated Validations for this Medical Packaging name change.
• Coordinating with additional site PM working on the same project to ensure consistency of implementation across sites.
• Prepares presentations, graphs, plans, forms, reports, etc. or any other document that is required to communicate project progress to management.
• Follows the standard operating procedures, rules and regulations established by entities related to the manufacture of medical products.
• Other responsibilities typical of the position as assigned by Project Management for this project.

• Start Time:	8:00 AM
  End Time:	4:30 PM