Quality Engineer

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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

  • Specialty:

    Engineering
  • Title:

    Quality Engineer
    • City:

      Maple Grove
    • State:

      MN
    • Zip Code:

      55369
  • Start date:

    09-12-2018
  • Status:

    Closed
  • Assignment Type:

    Contract To Hire
  • Job Id:

    46600

Description

Do you want to be part of a global leader in the medical device industry, yet have the ability to make an immediate impact for an ever growing organization? The DAVIS Companies is seeking a Quality Engineer that will drive process improvements across the board. 

Responsibilities of Quality Engineer:

  • Demonstrate knowledge of domestic and international requirements and standards such as FDA QSR Part 820, ISO 14971, ISO 13485, ISO 9001.  Support internal, corporate, notified body, FDA, and other audits
  • Drive improvements in shop floor quality control processes and procedures
  • Drive corrective, preventive, and closure actions for project issues related to quality and/or test nonconformance
  • Develop and improve the plant quality organization’s ability to perform complex problem solving to more effectively address customer complaints, service deviations and internal corrective actions
  • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary
  • Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement
  • Assist to develop and confirm methods for reprocessing of assigned devices
  • Write verification and validation documentation and conduct required testing as needed
  • Perform testing and inspection functions including forensics and root cause analysis
  • Author, revise, train, and provide support for production work instructions
  • Identify new processing needs and perform continuous improvement to support sustaining efforts
  • Participate in Design Reviews and identify improvements based on relevant risk analysis, past manufacturing experience, and Marketing/Customers’ specifications/requirements for products
  • Support cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements, scrap reduction and Supplier Quality improvement
  • Lead and facilitate process improvement activities and may include project management responsibilities
  • Committed to building a positive culture.  Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements

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