Employment

Quality Systems Manager

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Employment

Quality Systems Manager

Summary

Responsibilities include managing Quality Systems staff, oversee LifeCenter’s corrective action/preventative action (CAPA) system to ensure effective corrective actions, and overseeing Standard Operating Procedure/Policy (SOP) review to ensure compliance with regulatory standards. Assists in internal and external audits and oversees process improvement initiatives. 

Essential Job Duties/Performance Standards

  1. Manages the Quality Systems Specialists and assigned positions which includes working with the Quality Systems Director to establish departmental goals and evaluations.

 

  1. Oversees the internal investigations on deviations, nonconformities, complaints and the CAPA system to determine root causes and effective corrective actions.

 

  1. Oversees the SOP review to ensure compliance with regulatory standards.

 

  1. Oversees and ensures proper documentation control of organizational documents.

 

  1. Serves as an organizational administrator/liaison for multiple information systems; including document control and electronic medical records systems.

 

  1. Responsible for coordinating/verifying information system updates along with ensuring communication about updates to LifeCenter staff.

 

  1. Oversees quality improvement projects and training as directed by the Quality Systems Director.

 

  1. Assists the Quality Systems Director in the preparation for regulatory visits such as the Food and Drug Administration, Association of Organ Procurement Organizations, American Association of Tissue Banks etc.

 

  1. Collaborates with the Quality Systems department in the planning, implementation and management of internal and external audits.

 

  1. Performs organizational training on quality topics and other topics as assigned.

 

  1. Collaborates with the Quality Systems department and other departments to collect, analyze and trend data as assigned.

 

  1. All other duties as assigned by Quality Systems Director and the Executive Director.

Required Qualifications

  1. College Degree or equivalent.

 

  1. Have a minimum of two years’ experience in quality or related experience.

 

  1. Previous management experience.

Working Conditions / Physical Requirements

Work is performed in an office setting.  This position requires regular lifting, reaching, typing bending and walking.  You will be required to spend extended periods of time sitting.

Risk Exposure

Risk Exposure to Blood and Bodily Fluids:  There are no known essential functions of your position that may expose you to blood or bodily fluids.  LifeCenter's OSHA program will provide you with the appropriate procedures and guidelines.  If you need additional training or resources, please contact your manager/supervisor or the Health and Safety Officer.

Please include a cover letter detailing where you learned about this open position (i.e. FaceBook, LifeCenter website, third party website, referral, etc.).

To submit your cover letter and resume, e-mail a Microsoft Word or Rich Text Document to LifeCenter or mail or fax your resume to:

LifeCenter

Human Resources Department
615 Elsinore Place, Suite 400, Cincinnati, OH 45202

Phone: 513.558.5555  |  Fax: 513.578.6836  |  E-mail: Human.Resources@Lifepassiton.org