Manager, Medical Quality Assessment

Quest Diagnostics; Tampa (FL); Remote; USD 70,000 - 90,000; Full time

Job summary

A leading company is seeking a Quality Assurance Specialist to oversee compliance and quality activities across its laboratories. The role involves conducting inspections, managing quality issues, and participating in regulatory audits. Candidates should have a Bachelor’s Degree and significant experience in laboratory quality assurance.

Qualifications

• Three years experience in a laboratory with leadership responsibilities.
• Experience in laboratory quality assurance/quality control activities.
• Graduate of an NCCLS approved program or equivalent.

Responsibilities

• Conduct and lead inspections of domestic and international laboratories.
• Compose and submit timely inspection reports.
• Represent MQA on various quality-related teams.

Skills

Communication

Influencing

Collaboration

Problem Solving

Multi-tasking

Education

Bachelor’s Degree

BSMT, MLS, CLS Certification or equivalent

Tools

Microsoft Word

Excel

Outlook

Job description

Overview

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)%

Responsibilities

• 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, QMS 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”

Qualifications

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)

EEO

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