FULL-TIME, DAY SHIFT, 40 HOURS PER WEEK, MONDAY-FRIDAY, 8:00AM-4:30PM

SUMMARY:

The Quality Specialist acts as an active participant in the operation of HNL’s Quality Management Program, the internal and external audit processes and improvement programs. This role ensures regulatory compliance and external certification to quality standards.

PURPOSE:

The purpose of this document is to describe the general nature and level of work performed by personnel as classified; it is not intended to serve as an inclusive list of all responsibilities associated with this position.

ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.

1. Participates in the continuum of quality and quality structure for continuous quality improvement across the testing spectrum for improved patient safety.
2. Creates, embraces and emulates a culture of quality. 
3. Advises on the monitoring of QMP regulatory compliance. 
4. Makes recommendations on the evaluation and reporting of the performance of the QMP to management for review and improvement of the QMP.
5. Develops quality policies and procedures in accordance with regulatory requirements.
6. Maintains and coordinates elements of the document control management system. 
7. In coordination with the Manger of Quality and Regulatory Affairs, prepares quarterly QMP evaluations and assists with the preparation of the annual QMP evaluation report for the CLIA-holding Laboratory Directors and Director of Quality.
8. Identifies training needs and organizes training interventions to meet quality standards. 
9. Assesses, recommends, implements and directs others in coordination with Process Excellence Engineers to modify operational methods and practices to enhance department productivity with lean six sigma initiatives and reduce cost of poor quality.
10. Conducts root cause analysis investigations for nonconformance events with patient impact and/or patient  safety.
11. Investigates and tracks non-conforming events; participates in corrective and preventative action (CAPA) resolutions; evaluates and verifies CAPA to gauge effectiveness. 
12. Participates in investigation of incident reports, patient complaints, patient care issues and other issues requested by management. 
13. Advises on and participates in the monitoring of statistical quality data; identifies areas for improvement in the quality system based on trends; generates reports to communicate outcomes of quality activities. 
14. Contributes to the planning, scheduling, reporting and tracking internal assessments and onsite audits conducted by external providers and regulatory agencies. 
15. Proactively partners with Regulatory and Accreditation Specialist(s) to ensure compliance with regulations, guidelines and procedures. 
16. Represents the quality department on project teams. 
17. Partners with clients’ quality teams to identify continuous improvement opportunities; supports network quality councils’ patient safety reporting investigations and assures corrective action effectiveness. 
18. Promotes internal and external customer satisfaction and a culture of service excellence by meeting the customer’s quality expectations.

Required Skills

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Bachelors’ degree in a scientific field preferred.  At least five (5) years of hands on quality management experience.  Certification as a quality auditor (CQA or similar) is desirable.  Experience in design, development, coordination, preparation, implementation and support of performance improvement processes, internal audits and regulatory inspections.  Working knowledge of quality management in the clinical laboratory environment is recommended. 

Language Ability:

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format.

Math Ability:

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to compute average, median, and mean and to draw and interpret charts and graphs.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

Ability to use Microsoft office product , and various other computer software products including the Laboratory Information System.

Certificates and Licenses:

Certification by recognized certifying agency for quality professionals preferred (ASQ, NAHQ, ISO, etc)

Required Experience

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Bachelors’ degree in a scientific field preferred.  At least five (5) years of hands on quality management experience.  Certification as a quality auditor (CQA or similar) is desirable.  Experience in design, development, coordination, preparation, implementation and support of performance improvement processes, internal audits and regulatory inspections.  Working knowledge of quality management in the clinical laboratory environment is recommended. 

Language Ability:

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format.

Math Ability:

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to compute average, median, and mean and to draw and interpret charts and graphs.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

Ability to use Microsoft office product , and various other computer software products including the Laboratory Information System.

Certificates and Licenses:

Certification by recognized certifying agency for quality professionals preferred (ASQ, NAHQ, ISO, etc)