Senior Quality Engineer (Medical Device, Supplier Audit)

LeMaitre Vascular - Burlington, MA (30+ days ago)3.6

Overview LeMaitre Vascular is a leading global provider of innovative medical devices for the treatment of peripheral vascular disease. We develop, manufacture and market disposable and implantable vascular devices to address the needs of vascular surgeons and interventionalists. The company is listed on NASDAQ

Responsibilities This job position will be focusing on audits (internal, external and supplier). The position will require the management of the internal and supplier audit program and help support third party audits. They will work as team to support quality department improvement initiatives.

Internal audits will require the:

  • Generation of audit schedule, plans
  • Conduct audits
  • Review audit reports and generate finding reports
  • Feed findings into the CAPA process
  • Supplier Audits will require:

  • Supplier evaluation based surveys, certificates and on-site visits and maintenance of the supplier records.
  • Implement supplier initiatives
  • Travel is mainly in the U.S. and a couple of international visits yearly

  • Qualifications Bachelor's Degree from accredited four-year college or university in Engineering or Science

    6+ years of experience in medical device or pharmaceuticals

    Must have internal audit experience

    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.