Auditor, Quality Assurance

LeMaitre•Fox River Grove, IL

3d•$75,000 - $85,000

About The Position

This role is responsible for reviewing and assessing the medical suitability of human cardiovascular tissue donors for transplant. The position ensures compliance with FDA regulations, AATB standards, Good Tissue Practices, and the company’s Quality Management System.

Requirements

High School diploma.
Minimum of 2 years’ experience in quality assurance or a regulated healthcare/biotech environment preferred.
Experience reviewing medical records, donor charts, or clinical documentation a plus.
Knowledge of FDA regulations (21 CFR Part 1271), AATB standards, and Good Tissue Practices is highly desirable.
Strong analytical and problem-solving skills, with the ability to make informed decisions and escalate issues appropriately.
Excellent oral and written communication skills, with the ability to collaborate effectively with internal teams, external partners, and regulatory stakeholders.
Flexible, adaptable, and open to change, with a demonstrated willingness to accept responsibility and drive process improvements.

Nice To Haves

LPN, RN, or BSN related clinical experience preferred.

Responsibilities

Conduct comprehensive quality reviews of all records generated during tissue recovery, processing, cryopreservation, labeling, storage, and distribution, ensuring accuracy and completeness.
Evaluate medical documentation, including donor charts, autopsy reports, EMS records, serology, and culture reports, to determine donor eligibility and medical suitability for transplant.
Engage with recovery partners and other stakeholders to request clarifications, obtain additional documentation, and resolve discrepancies in donor records.
Ensure adherence to the company’s Quality Management System (QMS), FDA 21 CFR Part 1271 Good Tissue Practices, AATB standards, and internal policies and procedures.
Identify and escalate issues that may impact compliance, safety, or product quality, providing input to management for investigation, corrective actions, and process improvements.
Collaborate with cross-functional teams to streamline workflows, improve record accuracy, and enhance operational efficiency.
Perform additional responsibilities as assigned by management to support departmental and organizational objectives.