Medical Device Validation Engineer

Fort Wayne, IN

Job ID: 123409 Industry: Med

Validation SME (Working with Suppliers)

Environment:

Our client a large medical device company that manufacturers class 2 products. They are in need of a Validation Engineer to work with their existing suppliers.

Principle Duties and Responsibilities:

The consultant will be a senior level process validation consultant with 7-10+ years of experience. The consultant will be looking at the process validations of the clients suppliers. The consultant will be doing gap analysis on these process validations and determine what issues are present.   They will also be working with the suppliers to help them implement new validation procedures that are compliant and in line with the clients and FDA expectations,.

The consultant must be comfortable in a remediation environment. The consultant must have experience with process validation, and must be comfortable communicating with small suppliers that may not initially see the benefit of implementing new procedures and standards.

They must be able to finesse and communicate effectively with these suppliers to accomplish key milestones.

It would be ideal if the person had experience in any of the following special processes: cleaning, sterilization. Coating, welding, and test method.

Required:
  • Medical Device
  • Process Validation for medical devices
  • Experience working with Suppliers
  • Gap Assessment experience

Desired:
  • Sterilization
  • Coating
  • Welding
  • Cleaning

Job Type: Contract  

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