Quality Assurance Manager

HealthQuest Esoterics is a diagnostic laboratory that has been operating since 2015. We specialize in antigen, antiobdy, toxicoloy, and COVID-19 testing. We provide services to different types of facilities throughout the U.S.

Job Overview:

We are seeking an experienced Quality Assurance Manager to join our healthcare team. The QA Manager is responsible for communication between business-operation-QA, monitoring quality of operation, quality of pre-analytical and post analytical phases including reagent quality, methods performance, quality control values to ensure quality of test results, turn-around-time monitoring, client satisfaction related to testing results, attending to clients’ concerns/employees’ concerns, and quality improvement efforts.

Responsibilities:

• Ensure compliance and maintain awareness of various regulatory guidelines i.e., CAP, FDA, CLIA, HIPAA, OSHA, COLA, etc.
• Manage Quality Management System (QMS) which includes quality audits, quality metrics, monitoring of incident reports and corrective action.
• Oversee and manage document control and organization of records and ensuring all the records are organized, neat and readily retrievable.
• Continuous improvement of quality and processes.
• Provide support for internal/external complaint and deviation investigations.
• Develop and deliver training programs that teach the appropriate use of quality tools at work.
• Annually review and document the performance of all departmental personnel, if delegated by the Laboratory Director.
• Ensure that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.
• Report to the executive and laboratory management team the levels of quality achieved and identify those areas requiring improvement.
• Perform other duties as assigned.

SAFETY AND COMPLIANCE RESPONSIBILITIES

• Comply with applicable legal requirements, standards, and procedures including, but not limited to, those within the Compliance Process, Code of Conduct, State, COLA and CLIA.
• Report concerns and suspected incidences of non-compliance with our laboratory management.
• Cooperate with monitoring and audit functions and investigations.
• Ensure laboratory licensure is in good standing.
• Support a safe, clean, and secure working environment by supporting procedures, rules, and regulations.

Required Education and Experience

• Requires 4 years’ experience in Quality Management in a laboratory setting.
• Able to multi-task with a high degree of professionalism and diplomacy.
• Strong verbal and written communication skills.
• Demonstrate critical analysis and complex problem-solving skills.
• Demonstrate ability to manage quality and process highly confidential and proprietary information.
• Proficient in computer skills that include spreadsheets and word processing software, and Microsoft Office required.
• Knowledge of CLIA, COLA and State laws regarding laboratory operations.
• Knowledge of OSHA laws and regulations.
• Requires a Bachelor degree in a technical field, or equivalent combination of academic and work experience.
• Data entry/computer skills required.

Join our team! We look forward to hearing from you.