Specialist, Quality Assurance-Allograft

Overview:

The Quality Assurance Coordinator supports our Director, Regulatory & Quality Affairs for our Allograft business by assisting various quality and regulatory processes, projects, and administrative responsibilities.

Responsibilities:

• Performs quality systems functions including, but not limited to: CAPA’s, complaints, change controls, documents control, label controls, calibrations, equipment PM, and supplier/vendor qualifications
• Conducts internal audits of QMS as defined in policy as well as supplier audits and on-site audits for Recovery Agencies, critical suppliers and all applicable testing laboratories.
• Adheres to the Quality Management System (QMS) to ensure regulatory compliance with tissue banks SOPM’s, FDA regulations, AATB standards, Health Canada, HTA regulations and all applicable EU regulations.
• Participats in all regulatory inspections and audits from outside agencies.
• Maintains document control system is accurate and up to date.

Qualifications:

Associates degree, Bachelor’s degree or 2-3 years experience preferred.

Experience in quality systems and regulatory operations.

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.

Please contact LeMaitre HR at HR@lemaitre.com.