Quality Assurance Specialist, Senior. Hospital Lab, 40hr Days

Exemption Status:

Schedule Details:

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This position may have a signing bonus available a member of the Recruitment Team will confirm eligibility during the interview process.

At UMass Memorial Health, everyone is a caregiver - regardless of their title or responsibilities. Exceptional patient care, academic excellence and leading-edge research make UMass Memorial the premier health system of Central Massachusetts, and a place where we can help you build the career you deserve. We are more than 16,000 employees, working together as one health system in a relentless pursuit of healing for our patients, community and each other. And everyone, in their own unique way, plays an important part, every day.

I. Major Responsibilities:

1. Ensures practices, policies and activities are in compliance with the requirements of regulatory agencies such as CAP, OSHA, AABB, Joint Commission, DPH, FDA, ASHI and FACT; and ensures their readiness for associated review, inspection, reporting and application process. Develops and maintains appropriate policies.
2. Leads and assists in the management and execution of high level QA/Regulatory/Safety/Decision Support projects.
3. Ensures compliance with the Quality Management Program and all regulatory standards, to include the Lab's Quality System Essentials: Document Control, HR/Information/Occurrence Management, Assessment and Process Improvement, Customer Surveys, Laboratory Infection Control /Safety, and Patient Safety.
4. Ensures department's preparedness for regulatory inspections such as DPH, CAP and Joint Commission, FDA, FACT, and ASHI inspections. Conducts mock inspections and self-audits. Accompanies inspector and assists them in performing inspections.
5. Tracks and advises on industry standards for the regulatory and safety needs. In collaboration with appropriate staff, advises on prototype development, coordinates/conducts prototype, alpha and beta testing.
6. Ensures that Standard Operating Procedures (SOP's) exist for all procedures performed in the laboratory, and that the principles of document control have been applied.
7. Plans, develops, reviews, and documents training and educational programs for all personnel, including new employee orientation, annual safety training, SOP training, technical training, QI training, computer training, supervisory training and management training. Implements and tracks a formal staff competency evaluation program. Reviews, evaluates and monitors proficiency testing programs to ensure the adequate evaluation of test systems, methods and competency of personnel.
8. Responsible for risk management review to ensure that all complaints are properly investigated; and ensuring that procedures are in place for thorough investigation (Root Cause Analysis) and complete exception documentation.
9. Communicates department and hospital safety and regulatory policies and needs to technical and support personnel.
10. Plans and carries out complex comprehensive studies using a variety of available databases and software.

Standard Staffing Level Responsibilities:

1. Complies with established departmental policies, procedures and objectives.
2. Attends variety of meetings, conferences, seminars as required or directed.
3. Demonstrates use of Quality Improvement in daily operations.
4. Complies with all health and safety regulations and requirements.
5. Respects diverse views and approaches, demonstrates Standards of Respect, and contributes to creating and maintaining an environment of professionalism, tolerance, civility and acceptance toward all employees, patients and visitors.
6. Maintains, regular, reliable, and predictable attendance.
7. Performs other similar and related duties as required or directed.

All responsibilities are essential job functions.

II. Position Qualifications:

License/Certification/Education:

Required:
1. Bachelor's degree in Medical Technology or related field.
Preferred:
1. Master's degree in related field preferred.

Experience/Skills:

Required:
1. Minimum of 5 year's experience in clinical laboratories with knowledge of regulatory standards such as CLIA, CAP, AABB, FACT, DPH, Joint Commission and quality system management.
2. Strong interpersonal and communication skills, written and verbal essential.
Preferred:
1. Ability to apply computer applications, including MS Office products (excel) and EPIC.

Unless certification, licensure or registration is required, an equivalent combination of education and experience which provides proficiency in the areas of responsibility listed in this description may be substituted for the above requirements.

Department-specific competencies, including age-specific competencies and their measurements, will be developed and maintained in the individual departments. The competencies will be maintained and attached to the departmental job description. Responsible managers will review competencies with position incumbents.

III. Physical Demands and Environmental Conditions:

Work is considered sedentary. Position requires work indoors in a normal office environment.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

We're striving to make respect a part of everything we do at UMass Memorial Health - for our patients, our community and each other. Our six Standards of Respect are: Acknowledge, Listen, Communicate, Be Responsive, Be a Team Player and Be Kind. If you share these Standards of Respect, we hope you will join our team and help us make respect our standard for everyone, every day.

As an equal opportunity and affirmative action employer, UMass Memorial Health recognizes the power of a diverse community and encourages applications from individuals with varied experiences, perspectives and backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, gender identity and expression, protected veteran status or other status protected by law.

If you are unable to submit an application because of incompatible assistive technology or a disability, please contact us at talentacquisition@umassmemorial.org. We will make every effort to respond to your request for disability assistance as soon as possible.