Reports to: Chief Operating Officer
FLSA Status: Exempt (Salary)
Job Status: Full time
Location: Kansas City
It all begins with the unselfish decision to donate – an eye donor has passed away and wishes to help others through the gift of sight. This donation leads to the miracle of restored vision for the person who receives that gift through corneal transplantation. And right in the middle of this beautiful story is Saving Sight! Our mission-driven organization helped save the sight of 2,957 people last year.
The Regulatory and Quality Manager works in collaboration with operations and clinical leadership to build and maintain a quality program, ensure regulatory compliance and proactively seek continual improvement opportunities within the eye bank operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Oversight of quality department staff.
- Collaborate with all eye bank operations managers and key staff to ensure trusting working relationships are maintained between quality and operations.
- Reporting on quality program measures to management and stakeholders.
- Maintain the Standard Operating Procedures manual, including periodic revisions, updates to standard forms, and annual review.
- Quality assurance incident reporting, root cause analysis, trending and tracking of errors/departures.
- Corrective Action/Preventative Action development, implementation, and verification.
- Evaluate surgery outcome reports for distributed tissue and patient outcomes for distributed ASED. Investigate adverse reactions and follow up with regulatory agencies/institutions as appropriate.
- Deviation reporting to applicable agencies/institutions as required.
- Conduct internal and external audits as required.
- Coordinate, and conduct when needed, focused process audits.
- Provide insight on compliance and quality measures to new eye banking initiatives, processes, and programs.
- Maintain licenses and registrations for eye banking and processing operations with state, federal, and international agencies.
- Bachelor’s degree or equivalent experience from which comparable knowledge, skills, and abilities can be acquired is necessary.
- Continual training and certification as necessary
QUALIFICATIONS and EXPERIENCE:
- A minimum of five (5) years in a supervisory role and/or related leadership / management experience required, preferably in a quality role in a healthcare-related industry.
- Familiarity with all operational aspects of the donation process from referral through distribution.
- Knowledge of current eye banking standards and federal regulations is required.
- Experience with LEAN process improvement initiatives
- Ability to think strategically and plan work around attaining goals and objectives.
- Strong interpersonal, written, and verbal communication skills required.
- Strong organizational skills, critical thinking and problem-solving abilities with astute attention to detail.
- Strong leadership skills, ability to facilitate work teams.
- Ability to work independently, with limited direction, and in a team environment.
- Ability to work with distraction and to multi-task with frequent interruptions.
- Working knowledge of Microsoft operating systems, Microsoft Office, general database, and web-based applications. Experience with data analysis and spreadsheet calculations required.
- Must maintain a valid driver’s license and acceptable driving record as determined by Saving Sight.
- Must have reliable transportation.
- Normal office environment combined with normal outdoor exposures
- Paid time off
- Health insurance
- Dental insurance
- Healthcare spending or reimbursement accounts such as HSAs or FSAs
- Other types of insurance
- Retirement benefits or accounts
- Workplace perks such as food/coffee and flexible work schedules
NOTE: The preceding statements describe the nature and level of assignments normally given job incumbents. They are not an exhaustive list of duties. Additional duties may be assigned.
Saving Sight is an Equal Opportunity Employer. We take pride in the diversity of our staff, and seek diversity in our applicants. Saving Sight does not unlawfully discriminate on the basis of any status or condition protected by applicable federal or state law. Saving Sight reserves the right to seek, hire and promote persons who support the goals and mission of the institution.
Saving Sight - Kansas City, MO
Kansas City, MO 64153