Manager, Quality Assurance

Regulatory Jobs; Lewisville (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Regulatory Jobs seeks a Quality Assurance Manager to direct the daily training, supervision, and scheduling of QA staff in a clinical laboratory to ensure efficient operations and adherence to the Quality Management System.

The role supports the Quality Assurance Director and CLIA Laboratory Director in maintaining regulatory compliance, proficiency testing, internal audits, licensures, and client relationships, with a focus on continuous improvement.

Qualifications

• Five years in a clinical laboratory setting.
• Minimum one year of supervisory experience.
• Demonstrated knowledge of state and federal regulatory requirements for operating a clinical laboratory.
• Knowledge of CAP accreditation and ISO15189 standards is desirable.

Responsibilities

• Direct supervision to QA staff, including selection, onboarding, training, scheduling, and performance reviews.
• Ensure efficient operation and continuous improvement of the department.
• Oversee tracking of quality indicators, nonconformances, proficiency testing, internal audits, licensures, and client relationships.
• Prepare reports for QA Director and CLIA Laboratory Director and assist with inspections.
• Perform ancillary duties as assigned.

Skills

Quality Improvement

Team leadership

Communication skills

Regulatory compliance

Laboratory operations

Auditing

Education

Bachelor's Degree Required

MLS(ASCP) or equivalent license

ASQ preferred

Job description

The Quality Assurance Manager directs the daily training, development, supervision, and scheduling of department personnel to ensure optimal operational efficiency and a continuous workflow. This role oversees core quality functions and works with other Quality Assurance staff to ensure the laboratory’s Quality Management System is followed but also provides input on how it can be evolved. The Quality Assurance Manager directly supports the Quality Assurance Director and CLIA Laboratory Director in maintaining the laboratory’s compliance with internal policies, regulatory standards, and company procedures.

• Provides overall supervision to technical and administrative QA staff, managing talent selection, retention, onboarding, training, scheduling, performance evaluations, and counseling. The role directly supervises QA staff in the Specimen Management department. The role will monitor staff quality of service, deliver actionable feedback, and conduct comprehensive mid-year and annual performance reviews.
• Ensure efficient operation of the department to maximize employee utilization, maintain workflow continuity, and foster an environment of continuous improvement.
• The role works with and supervises Quality Assurance staff in core quality functions, including tracking laboratory quality indicators; documenting and tracking of nonconformances; enrollment and adherence to proficiency testing requirements; execution of the laboratory’s internal audit program; maintaining the laboratory’s licensures and accreditations; adherence to public health reporting requirements; maintain client relationships; and others as necessary.
• Prepare comprehensive reports for the Director of Quality Assurance and CLIA Laboratory Director, including Management Reviews. Assemble, maintain, and execute QA department standard operating procedures. Assist with offsite inspections as required.
• Performs other ancillary duties as assigned by leadership.

Direct Reports: 3

Five years in a clinical laboratory setting

A minimum of one year of supervisory experience

Knowledge:

• Demonstrated knowledge in state and federal regulatory requirements for operating a clinical laboratory
• Knowledge of CAP accreditation and ISO15189 standards is desirable

Skills:

• Demonstrated skills and training in Quality Improvement (e.g., Six Sigma, Lean, etc.)
• Proven track record in applying Quality Improvement methods
• Excellent communication skills, verbal and written
• Ability to work without direct supervision
• Demonstrated ability to lead a team
• Demonstrated ability to collaborate effectively across teams and functions

Education:

• Bachelor's Degree Required
• MLS(ASCP) or equivalent laboratory professional license required
• ASQ (any) preferred