Laboratory Quality and Regulatory Manager - Main Immediate Response Lab - Full Time - Days

The quality & regulatory manager is responsible for developing, leading, and driving operational quality processes in the clinical laboratory. This position will oversee and coordinate quality control projects, quality assurance program, performance improvement program and laboratory safety. The quality & regulatory manager will provide recommendations, action plans and guidance to the medical director and administrative director for the improvement of system processes in the laboratory.  Leads the laboratory quality team.

Quality: Maintains quality assurance and performance improvement (QAPI) program for the laboratory. Facilitates quality improvement initiatives, supporting section leads. Serve as the department administrator for quality event reporting (from internal and external lab sources) within the MIDAS system.  

 

Regulatory: Maintains accreditation functions of the laboratory including, but not limited to, College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments, (CLIA) and The Joint Commission. Maintains the proficiency testing (PT) program, CAP activity menu, and communications/responses to regulatory agencies.  

 

Facilitation: Participate in project management, change management and performance improvement methodology in the laboratory. Lead Kaizen events, root cause analyses and projects within the priority areas as assigned. Lead and/or support of leader of monthly QAPI, special projects, BLT and staff meetings as well as interdisciplinary meetings as needed.

 

Analysis and Reporting: Conduct on-going and focused analyses with available quality data to help identify priorities, improvement opportunities, trends and improved performance in all lab sections. Develop dashboards and reports for the laboratory.

 

Compliance Management: Provides oversight of the laboratory competency assessment program. Serve as the department administrator for the document control system.

 

Leadership: Provide leadership for all areas of the laboratory as delegated. Represent the laboratory on multi-disciplinary process improvement teams. Oversees Lab Quality team

 

Other: Perform and/or lead other projects and initiatives as requested by the medical or administrative laboratory director..

KNOWLEDGE AND SKILLS: 

 

EDUCATION: Bachelor Degree in medical laboratory science (medical technology) or health sciences required. Masters degree in related field preferred.

 

YEARS OF EXPERIENCE: 3 years of laboratory experience required. Laboratory leadership experience preferred.

 

REQUIRED SKILLS AND KNOWLEDGE: Knowledge of laboratory operations; familiarity with laboratory departments, functions and processes; business analytical and organizational skills; excellent written and oral communication skills; PC word processing, spreadsheet and presentation skills.   

 

 

LICENSES REGISTRATIONS &/or CERTIFICATIONS:

MT(ASCP) or MLS(ASCP) certification or equivalent required.