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Quality Engineer (Medical Device)

Company: HCL Technologies
Location: Irvine
Posted on: November 19, 2021

Job Description:

Degree in Mechanical, Materials or Biomedical Engineering with minimum 4 years of experience

  • Gap Assessment / review on existing change control Process & Documents.
  • Working independently with the internal and external stakeholders for execution.
  • Provides Quality Engineering support for commercial Medical products.
  • Applies knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
  • Ensures changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.
  • Apply various engineering principles including metallurgy, heat transfer, strength of materials, statics, sterilization, and biocompatibility.
  • Utilizes quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
  • Navigates complex government regulations to include FDA & QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971.
  • Present technical data to groups within and outside the organization.
  • Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Perform Test Method Validation and Process Validation.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devices and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

Keywords: HCL Technologies, Irvine , Quality Engineer (Medical Device), Healthcare , Irvine, California

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