Job Details

ID #22953910
State California
City Irvine
Job type Permanent
Salary USD Depends on Experience Depends on Experience
Source Tanisha Systems, Inc.
Showed 2021-11-18
Date 2021-11-11
Deadline 2022-01-10
Category Et cetera
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Quality Engineer

California, Irvine, 92602 Irvine USA

Vacancy expired!

Keywords:
  • 843 Remediation
  • Quality Engineer
  • Medical Device Risk Analysis
  • Job Description:
    • Degree in Mechanical, Materials or Biomedical Engineering with minimum 4 years of experience
    • Experience in 483 / Audit remediation for supplier related problems.
    • 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.
    • 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

    Vacancy expired!

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