Manager, Medical Quality Assessment

Davita Inc.; Tampa (FL); Remote; USD 70,000 - 90,000; Full time

Job summary

A leading company is seeking a Quality Assurance Specialist to oversee regulatory compliance within its laboratories. The role involves conducting inspections, preparing reports, and collaborating with various teams to enhance quality management practices. Candidates should possess a Bachelor's degree and significant lab experience, with preferred certifications enhancing their profile for this remote position requiring some travel.

Qualifications

• 3 years in a laboratory with leadership responsibilities.
• Experience in laboratory quality assurance/quality control and regulations.
• Graduate of NCCLS approved program or equivalent.

Responsibilities

• Conduct internal inspections of laboratories and prepare reports.
• Maintain knowledge of laboratory regulatory requirements.
• Represent MQA on company teams for laboratory testing.

Skills

Communication

Problem Solving

Team Building

Collaboration

Leadership

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

This position assesses quality activities for all Quest Diagnostics laboratories by, primarily, performing Quality Assessments to ensure compliance with regulatory standards and Quest policies.

This is a Remote opportunity.

Travel Required: (50- 60)%

• Conduct and/or lead internal inspections of Quest Diagnostics domestic and international laboratories. This includes the following: Esoteric laboratories, Regional laboratories, AmeriPath Diagnostics, Quest hospital laboratories (QHLs), rapid response laboratories, joint venture laboratories, point of care testing and contracted laboratories.
• Compose and submit timely and accurate inspection reports for corresponding inspections.
• Manage inspection responses to ensure completeness and accuracy.
• Maintain knowledge of laboratory regulatory requirements, to include accrediting bodies, federal, state, and local requirements as well as Quest Diagnostics policies.
• Represent MQA on various company teams/groups related to laboratory testing.
• Provide communication to the laboratories on relevant quality issues.
• Collaborate with National Laboratory Operations and Business Transformation teams.
• Serve as a resource and subject matter expert (SME) to laboratories for quality and regulatory issues.
• Participate in quality monitoring activities for Clinical Pathology, as required (e.g., metrics, Proficiency Testing (PT), CAP educational surveys, CAP, RQI, etc.).
• Prepare written communications and deliver presentations to laboratories, as required.
• Provide on-site consultation on quality and/or regulatory issues.
• Support and participate in special company-wide projects etc.
• Participate in annual continuing education and company training, as designated.
• Comply with all Quest Diagnostics policies including, but not limited to:
  • Employee Handbook
  • "Your Compliance Policy Handbook"

Required WorkExperience:

• Three (3) years-experience in a laboratory, including leadership responsibilities - required
• Three (3) years-experience in laboratory quality assurance/quality control activities, including laboratory regulations/accreditation requirements - required
• Experience managing a laboratory department, to include pre-analytic, analytic and post analytic QA/QC activities.
• Graduate of Graduate of NCCLS approved program or equivalent.

Preferred Work Experience:

• Supervisory experience in Immunology and/or Flow Cytometry
• Hospital work experience
• Experience conducting CAP or other regulatory audits

Physical and Mental Requirements:

• Maintain composure under pressure
• Adapts to change
• Ability to grasp information quickly
• Ability to multi-task
• Using effective verbal communication
• Using effective written communication
• Handle stress & emotions
• Making decisions
• Examine/observe details

Skills:

• Proficient in Microsoft Word, Excel, Outlook, etc.
• Possesses excellent communication (verbal and written), influencing, and collaboration skills
• Ability to work independently and effectively plan/organize work and projects
• Demonstrate team building and problem-solving skills

EDUCATION
Bachelor's Degree(Required)

LICENSECERTIFICATIONS

BSMT, MLS, CLS Certification or equivalent (Required)
ASCP Certification(Preferred)
Six Sigma Certified Green Belt (Preferred)

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.