Quality Assurance Manager

The Quality Assurance Manager aids the Vice President of Laboratory Services in regulatory and compliance tasks, ensuring adherence to industry standards and regulations. The Manager is responsible for the coordination, implementation, and ongoing assessment of the laboratory's quality management programs, covering all stages of patient testing—pre-analytical, analytical, and post-analytical. This role ensures compliance with all relevant regulatory bodies, including CLIA and The Joint Commission, while also developing and standardizing policies and procedures, managing proficiency testing, and overseeing training and competency assessments. The Manager provides strategic guidance on continuous improvement processes, corrective actions, and safety protocols within the laboratory environment.

• Quality Program Oversight
  • Implement and maintain patient test quality management processes across pre-analytical, analytical, and post-analytical stages.
  • Monitor laboratory operations and perform periodic audits to ensure compliance with laboratory policies and regulations. Report any areas of non-compliance.
  • Develop, implement, and manage policies, Standard Operating Procedures (SOPs), and Quality Management System (QMS) documentation.
  • Coordinate proficiency testing activities, ensuring timely enrollment, performance, and follow-up corrective actions for unsatisfactory results.
  • Track and report quality assurance indicators; prepare reports and data for senior leadership and regulatory agencies.
• Regulatory & Compliance Management
  • Coordinate regulatory inspections and ensure the laboratory remains compliant with CLIA, The Joint Commission, OSHA, and other federal, state, and local regulations.
  • Manage and maintain laboratory licenses, registrations, and ensure timely renewal submissions.
  • Serve as a resource to leadership and cross-functional teams regarding compliance and regulatory requirements, including the development of products and services.
  • Lead quality audits and report findings to leadership, ensuring continuous process improvement.
• Training, Competency & Safety
  • Design and oversee the training programs for laboratory staff on new policies, procedures, and quality control measures.
  • Conduct staff competency assessments and ensure ongoing professional development in line with industry standards.
  • Enforce the laboratory safety program through regular training, monitoring, and remediation to address non-compliance.
  • Ensure the laboratory remains in compliance with all applicable Hazardous Waste and Hazardous Communication programs.
• Continuous Improvement & Reporting
  • Develop and implement continuous improvement initiatives to enhance laboratory operations.
  • Compile and present an annual quality assurance report to leadership, summarizing achievements, challenges, and opportunities for improvement.
  • Provide leadership in establishing metrics for monitoring laboratory performance and quality improvement.

• EXPERIENCE
  • Required: At least 5 years of progressively responsible experience in clinical laboratory settings, with a strong focus on quality, regulatory compliance, and continuous improvement.
  • Preferred: Experience managing proficiency testing programs, audits, and regulatory inspections.
  • Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Access).
  • Experience with MediaLab, Laboratory Information Systems, and CareLogic preferred.
• EDUCATION:
  • Required: Bachelor’s degree in a related scientific or healthcare discipline from an accredited college or university.
  • Preferred: Master’s degree in a related field.
  • Required: Must meet CLIA qualifications for General Supervisor in a high-complexity laboratory.
  • Preferred: ASCP or equivalent laboratory certification.

BENEFITS AND PERKS: 

• PTO (Paid Time Off) 
• Immediately vested and eligible in 401k program with employer match.  
• Company sponsored ongoing training and certification opportunities. 
• Full comprehensive benefits package including medical, dental, vision, short term disability, long term disability and accident insurance. 
• Tuition Reimbursement after 1 year in related field  
  
  

We offer competitive compensation, comprehensive benefits, and a supportive work environment dedicated to your professional growth and development. 

Ready to shape our future by bringing in top talent? Apply now and be a key player in our success!