Coordinator level, non-supervisory role, reporting directly to Executive Director
The purpose of this position is to ensure that all employees and course participants are working in the safest environment possible and in compliance with all quality assurance, regulatory and accreditation requirements and laws by maintaining current knowledge of infection prevention and control procedures, understanding all AATB, OSHA, TOSHA and applicable accreditation regulations, providing training and coaching on proper policies, procedures, and techniques, and by monitoring compliance, the person in the position instills a safety and compliance consciousness in the organization that meets or exceeds the most rigorous standards. This person in this position will ensure compliance with MERI Standard Operating Procedures Manual (SOPM) to identify any violations and opportunities for improved quality and safety for Medical Director (Physician Advisor), Executive Director and other Management Team members.
ESSENTIAL JOB FUNCTIONS
(This is a summary list and not all inclusive of required job functions.)
Ensure AATB Standards Compliance throughout organization to maintain accreditation
Ensure release of Tissue Compliance
Ensure Compliance of employee training required per job description and maintain associated records
QA for various internal activities
Overall Radiation Compliance including oversight of administering radiation badge program
Review and Edits of Policies and Procedures that effect AATB accreditation, safety, course delivery compliance and infection control.
Infection Control and Prevention Safety Program administration
Partner with Outside organizations and societies to drive best industry practices (ABLE, ATTB)
Serve as liaison for all internal and external audits of organization
Assist and perform periodic compliance audits of bio-skills labs and courses
Ensure all organizational documents are in compliance with AATB and other standards (sponsor agreements, donor forms and internal control documents)
Serve as MERI's general Compliance Officer
Maintain CAPA reports and verification of effectiveness (VOE) as required
Perform any other related duties as required or assigned.
In order to perform this job successfully, an individual must be able to perform each essential job function satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION AND EXPERIENCE
Knowledge of a specialized field (however acquired), such as basic accounting, computer, etc. Equivalent of four years in high school, plus night, trade extension, or correspondence school specialized training, equal to two years of college, plus 5 years related experience and/or training, and 4 years related people/project management experience, or equivalent combination of education and experience.
REQUIRED CERTIFICATES, LICENSES, REGISTRATIONS
Note: CQA certification may be obtained while working within the position, but must be attainable within 12 months of taking on position. See requirements below.
REQUIRED SKILLS TO OBTAIN CQA CERTIFICATION:
Here are the requirements, experience and exam specifics for a Certified Quality Auditor.
Candidates must have worked in a full-time, paid role. Paid intern, co-op or any other course work cannot be applied toward the work experience requirement.
Candidates must have eight years of on-the-job experience in one or more of the areas of the Certified Quality Auditor Body of Knowledge. A minimum of three years of this experience must be in a decision-making position. "Decision-making" is defined as the authority to define, execute, or control projects/processes and to be responsible for the outcome. This may or may not include management or supervisory positions.
For candidates who were certified by ASQ as a quality engineer, reliability engineer, supplier quality professional, software quality engineer or quality manager, the experience used to qualify for certification in these fields applies to certification as a quality auditor.
Candidates who have completed a degree from a college, university or technical school with accreditation accepted by ASQ, part of the eight-year experience requirement will be waived, as follows (only one of these waivers may be claimed):
Diploma from a technical or trade school — one year will be waived
Associate degree — two years waived
Bachelor’s degree — four years waived
Master’s or doctorate — five years waived
Degrees/diplomas from educational institutions outside the United States must be equivalent to degrees from U.S. educational institutions.
These are the minimum expectations of a Certified Quality Auditor.
Must possess the knowledge and ability to effectively conduct different types of quality audits as appropriate for the method, or purpose of the audit and must recognize the effect those audit types will have on the audit scope and outcomes.
Must be able to audit in a professional, ethical, and objective manner using and interpreting applicable standards or requirements, with an awareness of potential legal and financial consequences of improper auditor actions.
Must be able to effectively plan, communicate, and execute an audit within its defined scope, including scheduling resources, conducting meetings and using appropriate techniques to identify, gather, and classify objective evidence.
Must be able to verify, document, and communicate audit results, develop an audit report, and evaluate the adequacy of the corrective and preventive action plan and follow-up.
Must possess interpersonal skills necessary to conduct interviews, make presentations, resolve conflict, and facilitate audits performed by other parties. Must possess knowledge of the responsibilities of the lead auditor and audit team member.
Must be able to select appropriate quality tools and auditing techniques for effective use in a variety of practical applications.
PREFERRED CERTIFICATIONS, LICENSES, REGISTRATIONS
Licensed Funeral Director or other Biology related degree
Certified Quality Auditor (CQA)
Certified Tissue Bank Specialist (CTBS)
Ability to read and understand documents such as policy manuals, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to effectively communicate information and respond to questions in person-to-person and small group situations with customers, clients, general public and other employees of the organization.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to prepare and interpret bar graphs.
CRITICAL THINKING SKILLS
Ability to solve practical problems and deal with a variety of known variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, or diagram formats.
The following physical activities 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 and expectations.
Semi-repetitive, low physical. Semi-repetitive type work which requires periods of concentration for varied time cycles as prescribed by the tasks.
While performing the functions of this job, the employee is continuously required to talk or hear; regularly required to sit; frequently required to use hands to finger, handle, or feel, reach with hands and arms; and occasionally required to stand, walk, climb or balance, stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move more than 100 pounds; regularly lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.
Position is essential to maintain AATB accreditation, compliance for course delivery and responsible for release of tissue as designated by the Medical Director.
Additional Salary Information: employee benefits (healthcare/dental/vision ins, life/add, short-term/long-term disability, 401k, etc.)
annual performance based bonus and merit increases likely
Internal Number: 1007
About Medical Education & Research Institute (MERI)
As a non-profit teaching and training bioskills lab, the Medical Education & Research Institute (MERI) supports essential medical training for the greater good.
Our central U.S. location and off-site availability allow us to facilitate state-of-the-art, hands-on educational courses for physicians, nurses, and other medical professionals from across the country and around the world. Our unique ability to coordinate all aspects of training is made possible in part by our exclusive partnership with the Genesis Legacy Whole Body Donation Foundation.