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Join our team and bring your expertise to a role where you can make a direct impact on quality, compliance, and patience care. As a regulatory subject matter expert, you'll leverage your laboratory experience and in-depth knowledge of regulatory requirements to guide compliance efforts, support inspections and audits, and help ensure the highest standards are met across the organization. Come do great work on behalf of better health!

POSITION SUMMARY
Provides effective system-wide support of quality assurance activities through guidance, consultation, and resolution of quality problems arising in system facilities. Provides quality improvement and problem solving techniques to all hospital and commercial sites and ensures standardization in quality assurance activities across the system. Interfaces with parent companies. Works closely with laboratory management and personnel to achieve system and laboratory specific quality and accreditation compliance goals, as required or as directed by Quality leadership.

CORE FUNCTIONS
1. Quality Management System: Upholds and supports a comprehensive quality management program, coordinating activities to assure compliance with all regulatory programs and retain a focus of standardization for both hospital and commercial operations, e.g.: interprets, educates, consults, advises, disseminates information, and evaluates compliance.

2. Organizational Quality: Assists laboratory management personnel in research, development, and implementation of new quality based policies, procedures, audits, metrics, process charts, and forms at various sites. Investigates quality related events and facilitates corrective action and preventative action measures. Facilitates Mock Inspections, Self-Inspections, Internal Inspections, on-Site Regulatory Inspections when requested or when indicated to assess compliance.

3. Education and Training: Fulfills education and training requirements by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies. Obtains 20 contact hours of continuing education through webinars, on-line training, preparing and presenting trainings, conferences, or other approved training. Assists in training utilizing preceptor and coaching skills and promotes a constructive environment that encourages learning and development.

4. Job Knowledge: Maintains professional and technical knowledge and awareness of quality regulations affecting laboratory operations to ensure compliance with Federal, State and organizational. Manages system integration projects. Incorporates regulatory, system, and process knowledge into investigations and process improvement projects. Serves as a resource to all system sites on regulatory requirements.

5. Financial: Evaluates order modification discrepancies and facilitates approval or rejection of requests according to policy. Upon approval, assists Sales and Marketing in client retention through facilitation of investigation of client specific complaints, client/patient letters, client visits, and client/patient calls. Incorporates financial impact evaluations into process improvement projects (e.g. Lead and/or participate in Lean/Six Sigma projects designed to improve financial performance and increase quality of care).
 

SCOPE AND COMPLEXITY

Responsible for all Quality services. Involvement in intra- and inter-departmental communications and activities. Internal customers – all employees within company. External customers – patients/clients, healthcare providers, physicians, support personnel. Has the ability to determine how best to accomplish functions within established quality guidelines function. Provides guidance in situations where procedures do not exist or are unclear, in concert with supervisor as available.

PHYSICAL DEMANDS/ENVIRONMENT FACTORS

Requires extensive sitting with periodic standing and walking. May be required to lift up to 20 pounds. Requires significant use of personal computer, phone and general office equipment. Needs adequate visual acuity, ability to grasp and handle objects. Must wear protective clothing as required and must use standard precautions due to threat of exposure to blood and body fluids. Ability to communicate effectively. May require off-site travel.

KNOWLEDGE, SKILLS AND ABILITIES

• Experience with Word, Excel, Outlook, PowerPoint.

• Demonstrated ability to lead and facilitate interdisciplinary teams.

• Analytical and conceptual systems thinking ability to balance and manage multiple projects simultaneously and good working knowledge of regulatory and accreditation requirements.

MINIMUM QUALIFICATIONS

• Bachelor’s Degree in clinical laboratory science, medical technologist or chemical, or biological science from an accredited college or university.

• ASCP, NCA, HEW, or other nationally recognized laboratory certification.

• Six (6) years’ high-complexity testing.

• Qualified as a General or Technical Supervisor as defined under CLIA ’88.

• Current knowledge of risk management, regulatory and accreditation requirements, and evidence of on-going participation in management continuous education.

PREFERRED QUALIFICATIONS

• LEAN and/or Six-Sigma Green Belt certification.

• Additional related education and experience.

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