Director, Quality and Compliance
About the Job
Are you a talented Director level professional who has had success collaborating, and implementing a national integrated Compliance, Quality and Risk Program for Clinical Engineering services? Take note... Sodexo is seeking a National Director for Clinical Engineering that would support the area of Quality & Compliance to preferably be based in Brentwood, Tennessee (suburb of Nashville, TN).
Is this opportunity right for you?
Working in Clinical Technology Management (CTM) for Sodexo, you will partner with our team and Healthcare clients to manage their clinical technology needs. Together, we provide leadership and expertise for their business, patients, residents and the staff who care for them. At Sodexo, we improve the Quality of Life of all those we serve.
We are seeking pro-active / solution-oriented candidates with proven success, who excel at managing a multi-faceted Clinical Engineering national programs focusing on compliance, quality and risk. If you get excited about being ahead of the pack on regulatory changes, ensuring day to day and forthcoming compliance issues are covered, managing risk and ensuring quality standards are continually enhanced, measured and adhered to, this is the job for you.
One of the key responsibilities will be to guide our organization through the ISO 9001 certification process. This role will work with our consultant and various members of our organization to develop, document and implement the CTM Quality Management Systems that meet the requirements of ISO 9001.
This impactful role requires an individual experienced, capable and committed to influence and drive critical pieces of the Clinical Engineering Operations nationally; will serve as SME, educator, auditor and quality and risk manager. This position serves as a resource for the implementation and maintenance of a coordinated and integrated Compliance, Quality, and Risk Program for Clinical Engineering throughout Sodexo CTM. The position ensures the directors, management and employees are in compliance with the rules and regulations of regulatory agencies and that company policies and procedures are being followed.
Duties and Responsibilities to include:
- Maintains a broad working knowledge in all healthcare regulations and understanding of health care regulations pertaining to the management of medical equipment. Continually improves knowledge of regulatory changes. Serves as a resource for all corporate /clinical / regional and corporate entities regarding compliance needs and regulation requirements for the management of medical equipment.
- Partners with operational / clinical / regional and corporate groups to conduct monitoring activities, implement corrective action plans and evaluate the effectiveness of the medical equipment management plan. Assesses various aspects of documentation as required by Federal, State, and other regulatory agencies for the management of medical equipment to ensure and enhance patient safety. Measures (survey, monitor, and report) compliance to Federal, State, and regulatory agencies.
- Develops, initiates, maintains, and revises policies and procedures for the general operation of the CTM Compliance Program and its related activities to prevent illegal, unethical, or improper conduct.
- Responds to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations.
- Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends
- Serves as a subject matter expert and resource to others and may act as an advisor for the compliance department, safety committees, risk, and the environment of care, specifically to be utilized in response to the management and use of medical equipment.
- Analyzes the results of internal and external compliance audits, equipment failure reports, equipment service reports, and all other Clinical Engineering Data, and utilizes this information to focus on potential education and implementation of corrective action plans to improve overall processes and documentation accuracy throughout the system.
- Conducts training sessions and audits of Clinical Engineering operational areas to assess and improve understanding of compliance, risk, quality, and regulatory requirements for the management of medical equipment.
CCE - Certified Clinical Engineer
CHTM- Certified Healthcare Technology Manager
Familiarity with ISO9001 certification process strongly desired.
Provides national support for Clinical Engineering program operations to include consistency of medical devices coding and nomenclatures, statistical analysis of device trends, and compliance to federal, state, and local regulations. Supports HIPPA, safety compliance, recall, alert, patient events related to SDX serviced equipmentThis position is devoted to program quality , regulatory compliance, data integrity, industry benchmarks, program safety, development and oversight of all policies and procedures for the business, and internal audit. Key Duties-Ensures compliance-Establishes programmatic consistency for CTM-Oversight of maintenance protocol for equipment-Provides statistical analysis of equipment maintenance trends-Supports the selling of new business-Responds to patient events related to serviced equipment
Qualifications & Requirements
Basic Education Requirement - Bachelor’s Degree
Basic Management Experience - 7 years
Basic Functional Experience - 7 years in maintenance and repair of clinical devices.
Sodexo is an EEO/AA/Minority/Female/Disability/Veteran employer.