Auditor, Quality Assurance

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

Overview

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.

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 elevate 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.

Qualifications

• High School diploma. 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 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 elevate 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.
• Fully onsite in Burlignton Massachusetts

Pay range $75,000-$85,000 per year plus bonus. The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education, qualifications, certifications, experience, and other job-related factors permitted by law.

EEO Statement

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.

This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.

Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at [e-mail].