Auditor, Quality Assurance

LeMaitre•Burlington, MA

3d•$75,000 - $85,000•Onsite

About The Position

This role reviews and assesses the medical suitability of human cardiovascular tissue donors for transplant. It ensures compliance with FDA regulations, AATB standards, Good Tissue Practices, and the company’s Quality Management System. The position is fully onsite in Burlington, Massachusetts.

Requirements

High school diploma.
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 and adaptable, open to change, and willing to accept responsibility and drive process improvements.

Nice To Haves

LPN, RN, or BSN-related clinical experience preferred.
Minimum of 2 years’ experience in quality assurance or a regulated healthcare/biotech environment preferred.
Experience reviewing medical records, donor charts, or clinical documentation is a plus.
Knowledge of FDA regulations (21 CFR Part 1271), AATB standards, and Good Tissue Practices is highly desirable.

Responsibilities

Conduct comprehensive quality reviews of 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, 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, and provide input to management for investigations, 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.