Bonfils Blood Center.
Department: Quality Assurance and Regulatory Affairs.
Requisition Number: JC10222.
Position Summary:
- Responsible for the effective implementation of Bonfils’ quality assurance processes related to collection, processing, testing, storage and distribution of blood and blood components.
- This includes equipment/ systems specification development, validation of equipment/systems, supplier quality management, process development, technical support related to quality problems, corrective action and continuous improvement change management, process control, statistical techniques, and non-conforming material and product disposition.
Minimum Education Required:
- Bachelor’s degree from an accredited college or university in Chemical, Mechanical, Electrical, Biomedical, and/or Industrial Engineering.
Preferred Experience:
- 5-10 years in validation of Equipment/Systems
- 5-10 years experience in quality engineering and process development
- 5-10 years experience in an FDA regulated environment such as Medical Device, Pharmaceutical, or Biologics
- 2-5 years experience in Continuous/Process Improvement, DMAIC/LSS, etc
Knowledge of the following quality systems:
- Process/Equipment validation
- Corrective Action and Continuous Improvement (CACI) also known as CAPA
- Non-conforming material and product management
- Process/Product development
- Statistical techniques via understanding of Statistical Process Control (SPC)
- Strong technical/engineering skills
- Strong written communication skills including writing, editing, and proof reading
- Strong interpersonal skills
- Computer skills
- Excellent oral communication skills
- Ability to handle multiple projects
- Ability to manage technical people and information
Review this and current employment opportunities:
Category: Quality/Compliance
Location: Colorado
Requisition Number: JC10222
For more information Contact: Julie Carroll, Employee_Recruitment@Bonfils.org
