- Leads the Quality function through oversight of the Quality Management System.
- Identifies and implements unique and varied initiatives aimed at improving patient care quality.
- Leads continuous improvement programs throughout the organization and helps develop a culture of continuous improvement and excellence.
- Collaborates with other executives and engages with leaders throughout the organization in a hands-on fashion to build quality, efficiency, effectiveness and a sense of shared accountability.
- Strengthens the data and information capabilities of the organization and championing a data-driven environment.
- Participates in Board of Director quarterly meetings as requested by CEO to provide information on ARUP’s Quality Management System.
- Provides reports on a regular basis, or as directed or requested, to the President and CEO and to the Board, to keep senior management informed of the operation and progress of quality efforts.
- Oversees ARUP’s document management system including Policies, Processes, and Procedures (SOPs).
- Collaborates with technical operations, IT and various other departments to define and implement a structured assay/product development and validation process consistent with the strategic direction of the business and regulatory requirements.
- Oversees CAP and ISO accreditation activities.
- Develops the department budget.
- Educates ARUP clients and prospective clients about the strengths of the Quality Management System.
- Chairs the ARUP Management Review Committee.
- Participates as a member of applicable ARUP committees that drives change, data enrichment and continuous quality improvement.
- Other duties as assigned.
- Master’s degree in Quality Management, Regulatory, Public Health, Healthcare Management or other applicable field.
- Strong working knowledge of CLIA, CAP, FDA, ISO, and other requirements applicable to clinical laboratories
- Strong leadership and project management skills.
- Fifteenyears ofexperienceas a key leader in Quality Management.
- Ten years of which must be in a clinical laboratory.
- Understanding of regulatory requirements for validated systems for clinical trials and companion diagnostics.
- ASQ Certification in applicable field
Physical and other requirements:
- Stooping: Bending body downward and forward by bending spine at the waist.
- Reaching: Extending hand(s) and arm(s) in any direction.
- Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.
- Communicate: Frequently and effectively communicates with others.
- PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.
- ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.
- Authorized to Work: Must be a citizen of the United States or authorized to work in the United States.
- Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
- Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
- Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.
- English: Ability to speak, read, and comprehend the English language.
- Continuing Education: Continual assessment of current literature and best practices.