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Quality Manager

Manager

Greenway Health | Quality and Regulatory | Tampa, FL

 

 

POSITION SUMMARY:
The Quality Manager is responsible for supporting strategic Corporate and Division objectives through the successful direction and execution of the Quality Assurance policies. Works closely with the business units to develop and audit processes to ensure compliant high-quality product development and services. Responsible for research, analysis, and documentation of quality approaches pertaining to EHR and Greenway Health products. Accurately documents the status of all Quality Management-related projects and communicates progress to the Leadership Teams. Provides leadership, supervision and guidance to Quality Management staff to ensure maximum team effectiveness and productivity.

 

 

DUTIES AND RESPONSIBILITIES:

  • Quality Management Activities:
    • Directs the management and maintenance of Greenway Health's Quality System to ensure compliance with ISO 9001, ONC and EHRA codes and Regulations to include:
      • Implementation of Quality System, Audit and CAPA activities
        • Approve all internal and external Quality System Audits outcomes, then leads corrective                     action  plans.
        • Approve all CAPA investigations and outcomes
      • Participates in trending analysis with Management
      • Directs a document control system and approves all controlled documents pertaining to the Quality             System.
      • Assist all departments in their development, update and implementation of Quality System processes.
        • Fosters an environment where functional roles own their processes and amend them as                       appropriate
    • Report the performance of the quality system to Leadership including CEO, to include Product and services               quality performance (dashboards) for all Quality system scope.
    • Leads all Quality audits and inspections.
    • Identifies proactively Quality Standards that may help the Company grow and organize
    • Influences Leaders and staff towards being proactive: seek quality on approach to Business activities, and use            audits as a confirmation it happens,
    • Escalates items as appropriate to the VP, Quality-Regulatory-Release Management.
  • Regulatory Activities:
    • Work in tandem with the Director of Regulatory Affairs:
      • Coordinates the regulatory documentation process for both regulatory submissions.
      • Proactively Research healthcare industry regulations and standards to:
        • Determine impact on Greenway Health
        • Coordinate efforts among departments to implement procedures to support regulations
        • Proactively Maintain Greenway Health compliance with applicable regulations
      • Disseminates information regarding product functionality that supports client compliance and                         provides a competitive advantage.
  • Sales & Marketing, RFP and Client Activities:
    • Assist with sales related activities including regulatory functionality and inquiries.
    • Participates in Greenway Health’s external audits conducted by clients/prospects
    • Work with Sales & Marketing, client focus groups, and other domain experts to identify product functionality             needed for client regulatory compliance.
  • Product Development:
    • Responsible for identifying and reporting recurring problems relating to software release along with                               recommendations for improvement. Major issues are escalated to Leadership and applicable Management.
    • Leads the Management Review of all issues leading to potential or acute risk to patient, maintains all related records with specific labels.

     

  • Process Improvement:
    • Creates and implements tools to automate processes that support quality & regulatory activities
    • Leads the Change Control Board for Greenway Health’s internal tools that pertain to the Quality System with IT Leadership.
  • Corporate Compliance:
    • Participates in Greenway Health’s external audits conducted by government agencies.
    • Work with the Finance Team to establish quality requirements for external suppliers.
    • ensures:
      • corporate compliance with all regulatory SOPs
      • corporate objectives, as they relate to the Quality System, are implemented and achieved in a timely            manner with clear reporting and coaching of impacted resources on achievement.
      • Leads Management review meetings and follow up
  • Team Management:
    • Sets and achieves meaningful division objectives supportive of strategic corporate objectives and team goals           in line with VP guidance
    • Responsible for conducting annual reviews and evaluations of direct report team members using established           standards and procedures.
    • Responsible for the development and implementation of standard, documented protocols and procedures                 relating to Quality Management.
    • Makes appropriate recommendations to Talent Management regarding division staffing.
    • Formulate and manage the development and implementation of policies, procedures and system tools pertaining to the Quality Management Team.
  • Corporate Education and Training:
    • Provides Leadership and all Teams and Business Units with up-to-date information regarding current and                   upcoming quality standards that affect our industry.
    • Serves as a resource to provide Quality knowledge and guidance to the Leadership Team and staff.
    • Provides quality knowledge transfer to all teams via documentation and training.
    • Provides counsel and training to suppliers regarding Quality requirements.
    • Participates in corporate training programs as assigned
  • Complies with all company SOPs as they apply to the Team and position.
  • Completes special projects as assigned

 


 

Skills & Requirements

JOB SPECIFICATIONS:

 

Education Required:

A Master’s or bachelor’s degree in a Clinical Science, Healthcare, Quality or related field. In-depth training in and understanding of quality system standards such as ISO 9001.

 

Experience Required:

  • A minimum of 3 to 5 years’ experience with the development of Quality Management systems is required.
  • Knowledge of regulations pertaining to EHR, Population health and healthcare revenue services is required.
  • Knowledge of healthcare systems industry standards and Software Development Life Cycles is preferred.
  • Broad experience and understanding of the applicable healthcare discipline is desirable.

 

Skills Required:

  • Excellent planning, project management and organizational skills.
  • Excellent analytical and problem solving skills.
  • Excellent interpersonal, oral, written, and presentation communications skills.
  • Excellent research and quality interpretation skills
  • Strong leadership and team-building skills with an ability to help others succeed
  • Ability to effectively audit processes and provide assistance in improvement activities
  • Excellent computer skills. Experience with MS Office (required)
  • Experience with MS Access, SharePoint, Adobe Professional, MS Project, smartsheets
  • Works effectively with all levels of staff across all divisions to reach desired goals.
  • Ability to define priorities and respond accordingly in a rapidly changing environment.
  • Ability to manage interruptions, work independently, yet perform effectively in a team environment
  • Must be able to communicate results, positive and negative, in a factual, detailed, and supported manner.
  • Must be very detailed oriented.

 

Travel Required:

Minimal travel is required.

 

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position the employee is regularly required to talk and hear verbal communication. The employee is frequently required to sit, and regularly required to stand and walk. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, and the ability to adjust focus. Moderate to extensive keyboard activity is required. Some lifting (up to twenty pounds) may be required.

 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Environmental conditions are somewhat variable, but generally acceptable in temperature, ventilation, and lighting with CRT/LCD exposure.