Medical Device Lead CSV Engineer

Boston, MA

Industry: Medical Device Job Number: 134123

Medical Device Lead CSV Engineer

Project Description:

Our client is a large medical device company currently seeking a lead CSV engineer to help write Master Validation Plans and test protocols as well as bridging the gap between the software in their devices and the software in their Quality Management Systems.

  Day to Day Responsibilities:

The consultant will be brought in as a lead CSV engineer to ensure the client’ s validation processes and procedures are efficient and compliant. They will be responsible for writing and executing IQ/OQ/PQs from a web-based software perspective. They need to be able to facilitate meetings with business reps to ensure they understand why certain records/documents/processes are compliant with CFR Part 11 or what must be done to get there. This consultant will be a subject matter expert that can take ownership of deliverables and figure things out on their own. They must be familiar with Part 11 Regulations and have experience validating cloud software, specifically Software as a Service (SaaS).

Required Skills:
  • Validating Web-Based Quality Systems
  • Computer System Validation
  • QA Experience
  • CFR Part 11
  • Writing Test Protocols
  • Creating Master Validation Plans
  • Validating Cloud-Based Software/SaaS Solutions

Job Type: Contract ?

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