Quality Assurance & Regulatory Compliance Manager Medipath, LLC Coral Gables, FL Job Details Full-time $100,000 - $135,000 a year 1 hour ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Employee discount Safety equipment provided Flexible schedule Life insurance Qualifications Microsoft Word Regulatory inspections Rulers Microtomes Cryostats OSHA Personal protective equipment (PPE) use Medical software Visual color comparison Safety regulations Spreadsheets CAP guidelines CMS Compliance audits & assessments HIPAA English Master's degree Proficiency testing CMS regulatory compliance Medical laboratory equipment Bachelor's degree Data management Attention to detail Health information regulatory compliance CLIA regulations Safety equipment Quality audits Laboratory information systems (LIS) Technical Proficiency Data analysis software

Full Job Description Job Location:

This position will initially be based in Coral Gables, Florida , and is expected to transition to Miramar, Florida by the end of 2026 .

RESPONSIBILITIES

• The listing of duties and responsibilities is not intended to be all-inclusive and may be expanded as the LD/TD may deem necessary from time to time. Lead and maintain the laboratory Quality Management System (QMS) across Histology, Molecular, Genetics, Chemistry, Hematology, and Cytology ("the Departments").
• Acts as a resource and subject matter expert for QA and regulatory compliance issues.
• Communicates and collaborates with staff to maintain and enhance quality and regulatory compliance.
• Identifies and resolves problems with quality and/or regulatory issues and communicates effectively with other departments, the Technical and Medical Directors, and medical professionals as necessary.
• Assists the LD/TD in developing, validating, and implementing new procedures and technologies within the department in context of an established QMP and regulatory compliance.
• Works with departmental Managers/Supervisors to train personnel in context of an established QMP (including QA manual) and regulatory compliance.
• Is committed to continuous Quality Improvement throughout the patient specimen journey from specimen receipt to final reporting.

Monitors quality metrics including turnaround times, specimen rejection rates, amended reports, critical values, proficiency testing, and quality control performance. Maintain laboratory quality dashboards and KPI reporting. o Perform internal quality audits and identify opportunities for process improvement. o Partner with departmental Managers/Supervisors to implement Lean, Six Sigma, or other continuous improvement initiatives. Assist department Managers/Supervisors in developing action plans to quickly identify and address quality deficiencies. Participate in client complaint investigations and service recovery when laboratory quality concerns arise. o Assist with risk assessments and implementation of quality improvement projects. o Perform trend analysis of quality data and present findings during Quality Management and Leadership meetings.

• Ensures Departmental compliance with CLIA, CAP, OSHA, HIPAA, and all other applicable local, state, and federal regulatory agencies.

Coordinates departmental adherence to CLIA and CAP regulations and inspection readiness. Responsible for the enrollment in proper CAP (or equivalent) proficiency testing programs, receiving proficiency testing specimens, administering the proficiency testing program including the review of proficiency testing reports and corrective actions as needed. Develops and maintains quality control and quality assurance programs to ensure the accuracy and reliability of test results, and ensure the lab adheres to CLIA regulations. Ensures MSDS sheets are available for all hazardous materials used in the departments and reviews annually. Ensures that departmental QMP, Safety, HIPPA, and waste management policies are followed.

QUALIFICATIONS

Minimum of a Bachelor's degree in Medical Laboratory Science, Biology, Chemistry, or related science (Master's preferred). ASCP certification (MLS, MT, MB, HTL, SCT, or specialty certification) preferred. Minimum of 5 years of clinical laboratory experience with at least a Minimum of 3 years of laboratory quality assurance or quality management experience. Strong knowledge of CLIA, CAP, CMS, OSHA, HIPAA, and laboratory regulations. Experience with proficiency testing programs, CAP inspections, and regulatory audits. Experience with quality and electronic document management software and laboratory information systems (LIS/LIMS). Ability to read, write and comprehend the English language at a level necessary for effective job performance, exercising correct English usage, vocabulary, spelling, grammar and punctuation, and communicate effectively, tactfully and positively in both oral and written form. Must be able to use independent judgment, to interact productively and positively with patients, physicians, providers, technologists, and staff. Must have excellent communication and interpersonal skills while acting as the laboratory liaison with extra departmental coordinators and staff. Must be able to balance and prioritize multiple projects with a great attention to detail. High level of critical thinking skills. Self-motivated, efficient, and very organized. Proficient computer skills in Word, Excel, spreadsheets and typing.

REQUIRIMENTS

• Successful completion of a pre-employment visual color discrimination test (ISHIHARA TEST).
• Proficiency and/or familiarity with computers, computer programs, information system, scanners, forceps, rulers, tissue dyes, scalpel or razor blades, microtomes, cryostats, water baths, slide rack, tissue processor, drying ovens, automatic strainers, cover slippers, and personal protective equipment (PPE).

ENVIRONMENTAL WORKING CONDITIONS/PHYSICAL REQUIREMENTS

Laboratory/Office work environment with exposure to various chemicals and equipment. Prolonged sitting, frequent walking, standing, bending, stooping and lifting up to twenty-five (25) pounds. Safety equipment and personal protective equipment provided and required. Requires normal range of hearing and manual dexterity sufficient to operate office and laboratory equipment. On-call status after normal hours of operations. Some travel required (conferences, client/prospective client visits). Laboratory Setting; exposure to communicable diseases, toxic substances, blood borne pathogens, chemical hazards and sharp instruments.

HIPAA/PHI SECURITY LEVEL

HIGH Low —information access is of general nature representing summary type data rather than specific identifiable demographic or sensitive data. Medium — information access is specific to an individual's demographics and service information (type of service, services received, dates of service, and provider of service). High — information access is detailed and sensitive to an individual's demographics, service information, and personal medical history (past/present medical conditions, specifics of medical diagnosis or tests, treatment plans, and family history).

Pay:

$100,000.00 - $135,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person