Medical Device Quality Engineer

Medical Device Quality Engineer at Advantage Technical Medical Device Quality Engineer at Advantage Technical in Prospect Heights, Illinois Posted in 3 days ago.

Type:

full-time

Job Description:

ONLY U.S. CITIZENS OR GREEN CARD HOLDERS WILL BE CONSIDERED

The Quality Engineer must have experience in the Medical Device, Pharmaceutical, or Biotechnology industry. You will be maintaining quality engineering programs, standards, and improvements within the organization. Develops and initiates standards and methods for inspection, testing, and evaluation. Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data. Develops and implements methods and procedures for the disposition of discrepant material and devises methods to assess cost. Directs workers engaged in measuring and testing products and tabulating data concerning materials, product, or process quality and reliability. Compiles and writes training material and conducts training sessions on quality control activities. Holds up Product Engineers and Quality Program Managers with customer interfaces as necessary on quality-related issues. Assures data availability and integrity for all quality-related data. Consolidates and reports quality results. Initiates corrective action requests as needed and tracks to satisfactory completion. Assists with the development and implementation of quality audits. In charge of developing, applying, revising, and maintaining quality standards for processing materials into partially finished or finished products. Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment. Explores reports and returned products and recommends corrective action. Establishes a program to evaluate the precision and accuracy of production equipment and testing, measurement, and research of equipment and facilities. Approves product, process, and equipment qualifications. Provides liaison to various regulatory bodies. Requirements Bachelor's degree in a related field or equivalent experience 6 years of quality engineer experience 3+ years of medical device, Pharma, or Biotechnology industry experience

ISO13485

CAPAS, SCARS, NCMRs experience ISO/FDA certification (preferred)