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Quality Manager Position: Anatomical Pathology lab, Dallas TX


posts: 2 1 stars user offline

Title: Laboratory Quality Assurance / Improvement Manager

Facility: Anatomic Pathology Laboratory

Relocation assistance provided

Reply with resume to:

 
POSITION OVERVIEW:

Direct, coordinate and maintain all regulatory and business process functions of Quality Assurance.

Insure fulfillment of Corporate Quality Improvement Program mandates at our clinical laboratory.

Reports to: Vice President, Regulatory Affairs

 

REQUIRED SKILLS:

Bachelor’s Degree and General Clinical Laboratory Scientist License required

10 years experience in a Anatomic Pathology/clinical Laboratory setting required including auditing and inspection experience preferred.

5 years of demonstrated leadership and management responsibilities.

3 years experience in laboratory Quality Assurance.

Quality related certification(s) such as Six Sigma/Lean Six Sigma preferred.

Knowledge of FDA and ISO regulations desirable.

Skills in training, validation, written/oral communication, and computer skills necessary to support the Quality Improvement activities are mandatory.

 
PRIMARY DUTIES:

Insure compliance with federal and state laws and regulations concerning clinical laboratory testing procedures and results.

Provide direction, oversee and manage facility specific Quality Improvement Program activities and operations which include Interdepartmental Quality Improvement Teams, Corrective and Preventative Action (CAPA) System, related Regulatory/Quality Training Program and Annual Quality Report/Initiatives/Plans to Management.

Evaluate, standardize and improve operational processes using appropriate industry standard quality improvement techniques.

Direct internal and external audit program for clinical laboratory operations, document audit findings, reports to Management and follow-up activities.

Oversee internal Proficiency Testing programs

Assist with the development and implementation of a harmonized, companywide Document System.

Maintain a compliant Document Control System at facility

Prepare and oversee facility specific Quality Assurance budget

Hosting and coordinating facility specific regulatory inspections. Business Quality Improvements

Coordinate and approve development of Corporate Quality and Customer directives with local procedures. This includes the development of the appropriate goals, metrics, and documents for the business

Direct and oversee the Quality Performance Improvement Board. Assure accurate and timely documentation for Customer Feedback and demonstrate continuous improvement to Customer Satisfaction Survey Measurements.

Insure Training and competency requirements are defined and achieved at the Business Units including programs for company wide use of quality tools and processes

Manage other assigned projects.


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