Responsibilities:

Develops and maintains a quality management system relative to the technical evaluation and improvement of services in relation to physician and patient care requirements. Documents all significant activities and recommends corrective action as necessary.

Facilitates compliance with all federal, state, local, TJC, CAP, CLSI, and other multi-disciplinary, hospital regulations, policies and procedures. Reports significant events to NMH management and Medical Directors as required.

Plans and facilitates departmental preparations for accreditation inspections. Responsible for inspections related to quality assurance, compliance and general laboratory policy and practice.

Reviews and catalogs departmental incident reports, non-conformances and critical incident reports. Prepares regular reports regarding tracking and trending of quality issues, and presents the findings to appropriate management personnel.

Provides assistance to senior staff in analysis and corrective action plan development in response to incidents.

Orients, trains and oversees activities of senior staff responsible for laboratory and departmental document control.

Serves as, or works in cooperation with, the department primary Safety and Emergency Management Officer, and/or the laboratory liaison with NMH Safety, Emergency Management and Environment of Care departments.

Orients, trains and oversees activities of the departmental Safety Officers to ensure compliance with hospital and regulatory agency requirements.

Provides training to departmental staff on quality, compliance and safety issues.

Authors and maintains their respective Laboratory Quality Plan, as required by applicable regulatory agencies.

Develops agendas and creates meeting minutes for department and hospital quality meetings.

Establishes ongoing quality data collection which enables monitoring of testing systems. Maintains knowledge and utilizes appropriate resources to provide consultative, educational, technical, or informational services as needed to self, staff or patients.

Manages departmental supply recalls in accordance with regulatory requirements.

Develops and supervises departmental operation audits and communicates results to laboratory management.

Conducts audits and evaluates and prepares reports recommending improvements in process and workflow for laboratory sections in compliance with DMAIC principles.

Assures that responses to audits, both internal and external, are well documented.

Authors and revises, as needed, departmental SOPS related to compliance, quality and laboratory general policies. Reviews and documents review of laboratory and departmental SOPS for compliance with regulatory standards and internal policies.

Assures that research activities performed in the section are in compliance with Hospital Research policies.

Maintains departmental quality, accreditation and regulatory records.

ADDITIONAL

FUNCTIONSDevelops and maintains a higher level of expertise in the specific areas of responsibility.

Participates in and presents at laboratory meetings and continuing education programs.

Participates in hospital quality and safety meetings as assigned.

LEADERSHIP/PROBLEM

SOLVINGAdheres to Patients First Management standards on leadership, communication and visibility.

Coordinates critical situations involving patients, staff, and visitors and consults with manager or administrator for guidance as needed (e.g., complaints, discipline, the press, etc.).Facilitates effective interdepartmental communication of incidents with appropriate personnel (Manager, Administrator, Medical Staff; etc.).Promotes philosophy and objectives of the Hospital, Division and Department.

Identifies and communicates key issues and trends to manager.

PROFESSIONAL/PERSONAL

DEVELOPMENTEstablishes and executes personal development objectives as part of annual objective setting process which complements current position.

Identifies and pursues activities/development opportunities which are appropriate for position and personal development objectives, e.g., participation/leadership in relevant professional groups associations, continuing education as participant, presenter, and planner.

Assesses and communicates staff development needs to Manager.

QualificationsMinimum Requirements:

Education:

Bachelors DegreeExperience:

Minimum 5 years experience in clinical laboratory, Transfusion Medicine, or Blood Gas Laboratory.

Clinical/professional expertise.

Behavioral Attributes:

Knowledge of CAP and TJC Standards; IDOT, OSHA and CLIA regulations; CLSI guidelines.

Knowledge of AABB standard and FDA regulations (applies to Blood Bank)

Other:

Valid driver's licenseWillingness and ability to travel to off-site locations

Preferred:

Masters Degree in related fieldExperience with quality systemsAmerican Society of Quality, CQAMT ( ASCP) certificationExperience as quality inspector or quality assurance officer.

Experience with the DMAIC quality system.

Additional InformationNorthwestern Medicine is an equal opportunity employer (disability, VETS) and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.

Background CheckNorthwestern Medicine conducts a background check that includes criminal history on newly hired team members and, at times, internal transfers. If you are offered a position with us, you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check. Results are evaluated on a case-by-case basis, and we follow all local, state, and federal laws, including the Illinois Health Care Worker Background Check Act.

Artificial Intelligence Disclosure Artificial Intelligence (AI) tools may be used in some portions of the candidate review process for this position, however, all employment decisions will be made by a person. BenefitsWe offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events. Please visit our Benefits section to learn more.

Sign-on Bonus Eligibility (if sign-on bonus offered for position): Internal employees and rehires who left Northwestern Medicine within 1 year are not eligible for the sign on bonus.

Exception:

New graduate internal employees seeking their first licensed clinical position at NM may be eligible depending upon the job family. 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Compliance Coordinator - Point of Care Testing, Full-Time, Days (Far West/Northwest Travel Coverage)