Manager, Medical Quality Assessment

Quest Diagnostics; Secaucus (NJ); Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Specialist to enhance compliance across its laboratories. This remote position involves conducting inspections, managing quality assurance activities, and ensuring adherence to regulatory standards. The ideal candidate will have a strong background in laboratory operations and quality control, along with excellent communication and problem-solving skills. Join a dynamic team where your expertise will contribute to maintaining high standards in laboratory services and fostering a culture of quality and compliance. If you are passionate about quality assurance in healthcare, this opportunity is perfect for you.

Qualifications

• 3+ years in laboratory quality assurance/control activities.
• Leadership experience in a laboratory setting is required.

Responsibilities

• Conduct internal inspections of laboratories for compliance.
• Manage inspection responses and maintain regulatory knowledge.
• Collaborate with teams on quality issues and provide consultation.

Skills

Microsoft Word

Microsoft Excel

Microsoft Outlook

Communication Skills

Problem-solving Skills

Team Building

Education

Bachelor’s Degree

Tools

Quality Management Systems (QMS)

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, including 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, including 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 Work Experience:

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

Preferred Work Experience:

• Supervisory experience in Clinical Chemistry, Immunochemistry, Autochemistry, and/or Special Chemistry.
• Hospital work experience.
• Experience conducting CAP or other regulatory audits.

Physical and Mental Requirements:

• Maintain composure under pressure.
• Adapt to change.
• Ability to grasp information quickly.
• Ability to multi-task.
• Effective verbal communication skills.
• Effective written communication skills.
• Handle stress & emotions.
• Decision-making ability.
• Examine/observe details.

Skills:

• Proficient in Microsoft Word, Excel, Outlook, etc.
• 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)

LICENSE/CERTIFICATIONS:

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.