• Quality Engineer

    Posted Date 2 months ago(9/27/2018 3:18 PM)
    Job ID
    2018-1328
    Type
    Regular Full-Time
  • Overview

    Plans and conducts activities concerned with the quality control and quality assurance of medical device manufacturing and design processes, materials, and products. 

    Responsibilities

    • Quality Representative for manufacturing process changes, product transfers and R&D projects
      •  Support Quality Control, R&D and Manufacturing with product and process validation work.
      • Lead the product and process risk evaluations 
      • Apply statistical techniques to product and process 
      • Create biocompatibility and sterilization strategies, execution and reports for product and process changes and the introduction of new products and processes. 
      • Develop test methods for testing, and evaluation. 
      • Devise sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data. 
      • Performs review and evaluation of supplier quality information in order to qualify the vendors including completing supplier audits.
    • Manage and improve assigned areas within the Quality Management System (QMS) including SOPs, work instructions, inspections.
    • Provide support during QMS audits                    
    • Implement new regulatory requirements within the QMS

    Qualifications

    Bachelor's degree (B. A.) from four-year college or university in physics, biology, chemistry, chemical engineering, mechanical or biomedical engineering; and a minimum of three to five years of experience in medical device industry.

     

    Travel may be necessary (10% or less) for auditing vendors, inter-company site visits or training.

    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.

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