Auditor, Quality Assurance
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Job Location:
Fox River Grove, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 companys 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 companys 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.
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 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.
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
Key Skills
- Laboratory Experience
- Quality Assurance
- FDA Regulations
- ISO 9001
- Quality Audits
- Quality Management
- GLP
- cGMP
- EPA
- QA/QC
- Toxicology Experience
- Aviation Experience
About Company
LeMaitre Vascular makes the veins run on time. The company makes both disposable and implanted surgical vascular devices, including catheters and stents, under such brands as AnastoClip, EndoFit, and Pruitt-Inahara. LeMaitre was founded in 1983 by vascular surgeon George D. LeMaitre, ... View more
