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Quality Engineer

Company: LeMaitre Vascular
Location: Burlington
Posted on: May 29, 2023

Job Description:

Uphold and improve the product quality of medical devices manufactured and uphold regulatory requirements.

  • Execute day-to-day activities based on quality objectives (goals) complementary to corporate policies and goals of building high quality medical devices

  • Evaluate medical device failures (product complaints) and write summary reports

  • Determine root cause and implement corrective and preventative actions

  • Complete a root cause analysis of the medical device or quality system failure

  • Audit the process to determine the root cause of failure

  • Summarize the root cause investigation for the CAPA

  • Develop a plan and timeline for the CAPA

  • Update standard operating procedures and work instructions to reflect the changes identified in the plan

  • Read and interpret standards in mechanical product, packaging and labeling for developing and updating standard operating procedures, and reviewing or creating protocols/reports

  • Evaluate risk in product and packaging design and the manufacturing process of medical devices

  • Audit the manufacturing process to confirm compliance to procedures used to manufacture medical devices for assembly, packaging, chemistry formulation of solutions, inspections and testing of the medical devices.

  • Update the quality system based on non-conformities found during internal and external audits.

  • Review non-conforming material reports for plan and disposition.

  • Analyze and report quality system data to the quality and manufacturing teams

  • Evaluate supplier performance based on data collected at incoming inspection

    Bachelor's degree or foreign equivalent in in Mechanical Engineering, Biomedical Engineering, or closely related and 2 years as a Quality or Validation Engineer or similar title, performing Quality Engineering at a Medical Device or Life Science company, including:

    • 1 year performing corrective and preventative action activities

    • 1 year performing risk management activities

    • 1 year in writing non-conforming material reports

    • 1 year collecting and analyzing quality system metrics

      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.
      ID: 2023-1980
      FLSA Status: Exempt (Salary)
      External Company URL:
      Street: 32 Third Avenue
      Post End Date: 6/12/2023

Keywords: LeMaitre Vascular, New England , Quality Engineer, Engineering , Burlington, Northeast

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