QA Auditor: Medical Tissue Donor Compliance

LeMaitre Vascular; Burlington (MA); On-site; USD 75,000 - 85,000; Full time

Job summary

LeMaitre Vascular is seeking a Quality Assurance Review Specialist to assess cardiovascular tissue donor records for transplant suitability. You will ensure adherence to FDA regulations, AATB standards, and Good Tissue Practices within the company’s QMS, coordinating with partners to resolve discrepancies.

The role emphasizes meticulous record review, documentation accuracy, and proactive escalation of issues to drive safety and quality across all processes.

Qualifications

• High School diploma; clinical experience preferred if LPN, RN or BSN.
• At least 2 years in quality assurance or regulated healthcare/biotech environment.
• 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.
• Strong analytical and problem-solving skills; ability to escalate issues appropriately.
• Excellent oral and written communication with internal teams, partners, and regulatory stakeholders.
• Fully onsite in Burlington, Massachusetts.

Responsibilities

• Review records generated during tissue recovery, processing, cryopreservation, labeling, storage, and distribution for accuracy.
• Evaluate donor medical documentation to determine eligibility and medical suitability for transplant.
• Engage with recovery partners to request clarifications and resolve discrepancies in donor records.
• Ensure adherence to QMS, FDA 21 CFR Part 1271, AATB standards, and internal policies.
• Identify and elevate issues that may impact compliance, safety, or product quality.
• Collaborate with cross-functional teams to streamline workflows and improve record accuracy.
• Perform additional responsibilities as assigned by management to support objectives.

Skills

Quality assurance

Records review

Regulatory compliance

Analytical skills

Communication

Adaptability

Education

High School diploma

LPN/RN/BSN clinical experience

Job description

LeMaitre Vascular is seeking a Quality Assurance Review Specialist to assess cardiovascular tissue donor records for transplant suitability. You will ensure adherence to FDA regulations, AATB standards, and Good Tissue Practices within the company’s QMS, coordinating with partners to resolve discrepancies.

The role emphasizes meticulous record review, documentation accuracy, and proactive escalation of issues to drive safety and quality across all processes.