To support our Succession Planning process and ensure the long-term success of MEDIC, we are adding a new leadership position within the
Quality Department:
Director, Quality. This newly created role will report directly to MEDIC's Chief Medical Officer (CMO). This role is a key component of MEDIC's ongoing succession and leadership development strategy. As we scale, it is crucial that we build a strong bench of leaders ready to guide our teams into the future. This is a rare opportunity to build on a strong Quality foundation while advancing our processes through innovation and technology. MEDIC is actively recruiting for this position, with an expected start date of late Fall 2026. Summary The Director of Quality position reports directly to the Chief Medical Officer (CMO) and functions independently from Operations. Responsible for ensuring MEDIC's compliance with applicable federal and state regulations as well as meeting voluntary accreditation standards and contractual requirements. Coordinate development and amendment of MEDIC's Standard Operating Procedures (SOPs) and state and federal license applications. The Director of Quality is responsible for trending key quality information for management review and use in process improvement activities and is accountable to administer Quality Program Elements as described in the Quality Plan. Essential Duties & Responsibilities Directs, manages, and monitors the Quality department to ensure all activities are compliant with licensing and accreditation requirements. Lead regulatory, accreditation, and consignee inspections. Oversee internal and external audit programs related to Quality. Manage deviation investigations, CAPA systems, and error-prevention processes. Own SOP lifecycle management and document control systems. Oversee equipment qualification and validation programs. Direct quality-related training and competency assessments. Partner with executive and operational leadership to align quality strategy with organizational goals. Ensure compliance with FDA, AABB, CLIA, cGMP, and all applicable regulatory standards.
KNOWLEDGE
| SKILLS |
ABILITIES
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, Board of Directors, and the general public. Ability to solve problems at an expert level through interpretation of regulatory guidelines, applicable laws and statutes, industry standards, and quality focused decision making. Ability to maintain confidentiality of donors, customers, employees and MEDIC business information. Familiarity with regulatory/legal compliance standards such as FDA regulations, GMP, CGMP, and related frameworks.
EDUCATION
|
EXPERIENCE
Required Bachelor's degree in relevant scientific field or equivalent level of education and experience. Minimum five years in a highly regulated, compliance driven environment with responsibility and oversight for designing, implementing and monitoring the quality programs. Demonstrated experience working as a strategic partner with Senior Leadership and Board of Directors. Preferred Quality Certifications such as
ASQ CQA, ASQ
CMQ/OE or similar professional Quality certification. Valid Medical Technologist license in Tennessee. Blood Banking Experience. Join us as we uphold the highest standards of quality through innovative practices and unwavering commitment to excellence! MEDIC Regional Blood Center is an equal opportunity employer, and it does not discriminate against otherwise qualified applicants on the basis of sex, race, color, religion, national origin, creed, pregnancy, age, disability, genetic information, pas, present, or future status in the Uniformed Services of the United States of America or any other status or characteristic that is protected by federal, state, or local law. All job offers are contingent upon the successful completion of a satisfactory drug screen and background check. Submitting this application does not constitute an offer of employment. MEDIC Regional Blood Center participates in the TN Drug Free Workplace program and E-Verify. About
MEDIC MEDIC
was established in 1958 by Carl Nelson, MD, under the sponsorship of the Knoxville Academy of Medicine. Area physicians supported the independent, not-for-profit blood center because they wanted a source of blood from volunteer donors, and they desired centralization of blood collection, testing and distribution. MEDIC's operational and capital costs are financed by blood supplier processing fees charged to hospitals. MEDIC is the only U.S. blood center which has a Blood Coverage Program covering members' blood supplier processing fees at any hospital in the country. MEDIC is a member of America's Blood Centers and is an accredited member of
AABB. MEDIC
Regional Blood Center is East Tennessee's primary blood supplier—saving lives through local donations that stay in our community. Give local. Save Local. MEDIC Regional Blood Center is the provider of blood and blood-related products for 24 hospitals in 23 counties in East Tennessee and Southeastern Kentucky and regional air transport services.
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Referral program Relocation assistance Vision insurance
Education:
Bachelor's (Required)
Experience:
Regulatory Environment:
5 years (Required) Blood banking: 2 years (Preferred)
License/Certification:
Quality Certification (ASQ
CQA, ASQ
CMQ/OE or similar ) (Preferred) Medical Technologist license (Preferred) Ability to
Relocate:
Knoxville, TN 37921: Relocate before starting work (Preferred)
