Quality Engineer

Posted:
06/18/18
Type:
Full Time
Location:
Sanford, FL
Category:
Engineering, Information Technology
Salary:
DOE
Job ID:
101417

New Opportunity!

Ashley Ellis is looking for a great Quality Engineer to work with a great team at a growing company in the Sanford, Florida area. This Quality Engineer will be expected to provide Quality support for medical products and provide feedback, reports, and solutions, when needed.  This is a great position for anyone that is looking to work on a variety of tasks throughout the day, while being a part of a fast-paced team environment.

This Quality Engineer will be expected to:

  • Conduct investigations into complaints for products with respect to regulations including 21 CFR 820, 803 and in accordance with ISO13485
  • Identify potential root cause and assess potential finished device impact
  • Follow up on CAPAs for completion and effectiveness
  • Write and approve investigation findings
  • Work with company personnel to inform, recommend, and provide assistance relevant to complaint investigations
  • Participate in Risk Analysis, including FMEA and PFMEA
  • Collaborate and effectively work well with others

 

This Quality Engineer should have:

  • Bachelor’s Degree in Engineering, or related field
  • 3+ years experience process, quality or investigatory engineering
  • Experience with root-cause investigation tools
  • Experience with FDA regulations and ISO13485
  • Effective problem-solving and communication skills
  • Ability to work well with others
  • Knowledge of MS Word, Excel, PowerPoint, and Access & Visio

This Quality Engineer will enjoy:

  • Working with many different tasks
  • Working alongside many different types of people
  • Competitive benefits