Case Study: Staff Augmentation Program

  • QualityHub
  • January 5, 2020
  • 2-Minute Read

Staff Augmentation Case Studies

At QualityHub, we have experience in staff augmentation for several types of companies and roles. Here are four examples of staff augmentation case studies to give you some background on that experience.

1. Multiple Roles – Consent Decree

Staff Augmentation Case Study

For a client under a consent decree, we provided manpower to work within the quality organization due to a lack of personnel on the client end. These projects were six months to over a year. The positions we filled on a temporary basis were:

  • Acting/Interim Quality Manager
  • Acting/Interim Complaints Manager
  • Acting/Interim CAPA Manager
  • Acting/Interim Sustaining Engineering Manager

2. Quality Manager – Warning Letter

Staff Augmentation Case Study

For a client under a warning letter, we provided an acting/interim quality manager. This person managed the day-to-day quality organization as well as the efforts to address the warning letter and prepare for an FDA reinspection. The duration of the project was over 18 months. For this project, the client was so happy with the individual they asked if he could serve as acting/interim vice president of quality.

3. Senior Advisor – Warning Letter

Staff Augmentation Case Study

For a client under several warning letters, we provided an acting/interim quality management system senior advisor who provided two specific scopes of work over a 12-month duration:

  • Served as the corporate-level project architect for a company-wide risk management program
  • Served as a coach to an incoming corporate quality vice president

4. Audit Program Manager – Medical Device

Staff Augmentation Case Study

For a medical device client, we provided an individual who served for over six months as an acting/interim internal audit program manager. This individual also performed several audits in numerous countries while serving in this capacity.

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About the Author

QualityHub is a top FDA compliance consultant company headquartered in Orlando, FL. Serving internationally, QualityHub delivers customized quality system solutions for navigating medical device and pharmaceutical FDA regulations.