Sr. Specialist, Quality Assurance - Internal Audit

Location

Burlington, MA | United States

Job description

As Sr. Specialist, Quality Assurance, he/she will perform task that will uphold and improve the product quality of medical devices manufactured and meet regulatory requirement to stay in compliance.

• Executes day to day activities based on quality objectives (goals) complementary to corporate policies and goals of building high quality medical devices.
• Audits the QMS and coordinates with external agencies to complete internal audits
• Prepares and Leads External Audits (MDD, MDR, ISO13485, MDSAP, UKCA)
• Updates the quality system based on non-conformities found during internal and external audits
• Leads and implements compliance and process improvements in Manufacturing and Quality Systems
• Determines root cause and implements Internal Audit Findings and Corrective and Preventative Actions
• Completes a trace matrix for new standards affecting the QMS
• Analyzes and reports quality system metrics

B achelor's degree (B.A.) from four-year College or university preferrably in Science or Engineering; and a minimum of six of experience in the medical device industry.

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 [email protected].

Job tags

Salary