Remote QMS Software Validation Manager

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Wed, Sep 02, 2020

This job expires in 8 days

Job Category: Information Technology

Remote Level: 100% Remote

Employer Type: Employer

Career Level: Experienced

Job Summary

A diversified technology company has a current position open for a Remote QMS Software Validation Manager.

Individual must be able to fulfill the following responsibilities:

  • Ensure that new software and changes to existing software or infrastructures are validated before approval and use
  • Define and establish a lean practice
  • Ensure the accuracy, completeness and compliance of SW validation deliverables

Required Skills:

  • Experienced with IT software applications development and SDLC methodologies from requirements to validation
  • Bachelor’s degree plus a minimum of 7 years of related experience in the medical industry
  • Expertise in validation of enterprise wide quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines
  • Strong background in FDA, ISO and EU regulations for medical devices and healthcare