Quality Assurance Manager

Join an international team working to improve the future of healthcare and enhance the lives of millions of people at Grifols, a global healthcare company.

Requirements

• Bachelor of Science degree or equivalent
• Maintains oversight of the center's quality management system and ensures continuous quality improvement
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations
• Maintains oversight of center training program
• Responsible for the personnel functions of the Quality Associate
• Responsible for oversight of all aspects of internal and external audits
• Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints
• Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans
• Oversees product and biohazard waste shipments
• Performs a review of the documentation of unsuitable test results and unit lookback information
• Performs a review of donor adverse event reports and the applicable related documentation
• Ensures that job and center annual training is completed, documented, and on file
• Performs employee training observations to ensure staff competency prior to releasing employees to work independently
• Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions
• Determines donor suitability activities and manages donor deferrals as appropriate
• Reviews and approves of deferred donor reinstatement activities
• Prepares quality analysis reports to track issues and set goals
• Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented
• Holds monthly Quality Meeting to communicate status updates and manage action outcomes

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan