Quality Engineer I

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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Quality Engineer I

  • Specialty:

    Engineering
  • Title:

    Quality Engineer I
    • City:

      Cordova
    • State:

      TN
    • Zip Code:

      38016
  • Start date:

    06-14-2019
  • Status:

    Closed
  • Assignment Type:

    Contract
  • Job Id:

    49742

Description

Job Purpose

The Quality Engineer I provides Quality Engineering support to Manufacturing, Engineering, QC/QA, and Process Development and IT teams to ensure that products are manufactured with a high level of quality, while being in compliance with regulations governing medical device manufacturing.

Responsibilities

  • Support software validation efforts including, but no limited to: evaluating software changes, test script review, validation documentation
  • Become proficient in validation efforts
  • Project and process planning and execution skills to ensure regulatory requirements (e.g. design control) and process/product goals (e.g. process capability) are met
  • Work with multiple project schedules and manage competing priorities
  • Support design transfer activities focused in development of gage design, inspection processes, capability studies and process/software validation
  • Facilitate Design Review activities of new products and work closely with product design teams to ensure quality considerations during all stages of product development, including software development
  • Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams
  • Support activities related to supplier control and management
  • Support Quality Systems such as delivery holds, lot release, internal and external audits, CAPA and investigations
  • Provide guidance and help solve significant or chronic process, product or software problems. Discuss customer problems with Marketing and Sales as needed
  • Become proficient with SAP applications that track internal and external failures
  • Identify specification needs/requirements and assist with the creation/updates of specifications
  • Become proficient in root cause analysis techniques (e.g. fishbone diagrams, 5-Whys, process mapping, etc)

Education and Experience

  • Bachelor’s degree in an Engineering or Science discipline or equivalent technical background, with emphasis in Quality or related fields preferred.
  • Data analysis and critical thinking skills
  • Ability to adapt and learn quickly
  • Good written and verbal communication; responsiveness
  • Ability to work well within a team and relate to all levels within the company
  • Conducts investigations and trains personnel on methods and statistical analysis tools.
  • Experienced in the use of quality tools such as Failure Modes Effects Analysis (FMEA), Fish Bone Diagram, Risk Analysis, or other appropriate methods to define and manage risk or identify root cause of failure. Understanding and experience in applying quality assurance and control tools (statistical analysis, DOE, gauge R&R and SPC).
  • Strong working knowledge of process development and validation methodologies (IQ,OQ,PQ) for process and software applications.
  • Experience interacting directly with suppliers, Manufacturing, and Manufacturing support organizations.
  • Must have 1 to 3 years of experience in working within the medical device industry and have the understanding of, and ability to interpret, regulations and guidelines governing medical devices including knowledge of ISO 13485 and 21 CFR 820- Product Management experience is a plus
  • GD&T knowledge/experience (preferred).
  • Software quality assurance experience (preferred)

Please call 901-209-5950 or email your resume's to hlocke@daviscos.com for consideration!

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