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Quality Engineer in Naples, FL ,  at Arthrex

Date Posted: 11/20/2018

Job Snapshot

  • Employee Type:
  • Location:
    Naples, FL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Requisition ID:
Quality Engineer
Arthrex, Inc.
Naples, FL

“Come join one of the best Quality Assurance teams in the world where you’ll have the ability to influence key business initiatives through the evaluation, investigation, and trending of medical device performance issues.  Help Arthrex make their products better by working with a team of professionals dedicated to achieve better patient outcomes through continuous improvement.  Our team works hand in hand with Product Management and Design Engineering to track real world performance, find the issues, and resolve them.  At Arthrex, you’ll have the ability to make a difference!”

Main Objective:

Drive product improvement through performing complaint investigations using failure analysis techniques to identify root cause.  Use your passion for engineering and failure analysis to identify the how and why of failure modes for orthopedic surgical tools and other medical devices.

Essential Duties and Responsibilities:

  • •Perform failure analysis of medical devices through complaint investigations and record detailed observations of returned products as received.

    •Test returned product according to established specifications and record detailed results with an emphasis on consistency.

    •Determine root causes of non-conformances discovered.

    •Identify, collect and analyze data to support the company commitment to quality products.

    •Summarize non-conformance and root cause trends by products and product families.

    •Use risk analysis tools to evaluate product and system safety issues.

    •Participate in regularly scheduled customer team feedback meetings where product performance data is trended, analyzed, and discussed.

    •Provide statistical analysis of data for complaint trending and product improvement.

    •Act as liaison between Product Surveillance and other departments to follow up on action items generated during customer team feedback meetings.

    •Work directly with the Design, Manufacturing, Product Management, and Quality Engineering teams to drive continuous improvement and product improvement.

    •Works with leadership to develop and deliver reports from various applications.

    •Works with leadership to identify areas where efficiency and process improvements can be made.

    •Identify and present quality issues with risk based prioritization.

    •Participates in FDA and ISO audits and internal audits as required.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

  • Bachelor’s degree in Engineering or Engineering Technology required.
  • 3 years engineering experience conducting and facilitating complaint investigations towards root cause required.
  • Experience working in a regulated industry such as medical device, pharma, defense, etc. required.  Medical device experience strongly preferred.
  • Experience with business or technical writing strongly preferred.
  • Experience working with personnel of various skills sets and education levels; ability to interface with personnel across multi-functional departments preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Working knowledge of FDA 21 CFR 820, cGMP, and ISO13485:2003 or later required.

Excellent and proven interpersonal and communication skills preferred.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and MS Office programs, particularly MS Excel, MS Access, and MS Word required.

Experience using SAP preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.