Quality Assurance Auditor - Tissue Documentation

LeMaitre Vascular; Burlington, Northern (MA, KY); Hybrid; USD 33,000 - 47,000; Full time

Job summary

LeMaitre Vascular in Burlington, MA is looking for a detail-oriented QA/QC professional with experience auditing documentation across recovery, processing, cryopreservation, labeling, storage and distribution of tissue products.

The role emphasizes ensuring compliance with FDA 21 CFR Part 1271 and AATB standards, performing chart audits, data entry, and document control, while using MS Office and communicating in English.

Qualifications

• High School Diploma or GED required.
• 1-2 years of related experience.
• Posses the ability to learn on the job and develop critical thinking skills.
• Microsoft Office

Responsibilities

• Responsible for quality review of documents generated during recovery, processing, cryopreservation, labeling, storage, and distribution of tissue.
• Responsible for making sure company is compliant with adhering to Good Tissue Practices established by FDA 21 CFR Part 1271, AATB and company procedures and policies.
• Auditing charts –Auditing Batch Records and Data Entry.
• Auditing labels and uploading documents into Vitals database.
• Audit RFA culture reports and file donor charts.
• Adheres to company policies, procedures, and documentation requirements.
• Treats others with courtesy, sensitivity, and respect at all times.
• Other duties as assigned.

Skills

Fluent in English

Education

High School Diploma or GED

Tools

Microsoft Office

Job description

LeMaitre Vascular in Burlington, MA is looking for a detail-oriented QA/QC professional with experience auditing documentation across recovery, processing, cryopreservation, labeling, storage and distribution of tissue products.

The role emphasizes ensuring compliance with FDA 21 CFR Part 1271 and AATB standards, performing chart audits, data entry, and document control, while using MS Office and communicating in English.