Quality Engineering Consultant

Austin  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

Quality Engineering Consultant:

Specific responsibilities:
  • Review inspection / quality plans and determine impact to resources.
  • Research design features to determine risk to quality / function / patients
  • Develop risk analysis of product features.
  • Research complaints and non-conformance material reports to develop historical data
  • Update inspection sheets (Microsoft Word) and route through ECO process (Agile / Oracle)
  • Present findings and make recommendations to engineering teams
Qualifications
  • Bachelor of Science in the Engineering required, Mechanical or Biomedical preferred
  • Medical device experience required - 5+ years
  • Orthopedic experience, specifically in the total joint space (knee, hip, shoulder) - 3+ yrs
  • Understanding of inspection techniques (gages, fixture, CMM, vision systems, etc)
  • GD&T understanding, doesn't have to be an expert but needs to know what GD&T is and basic principles
  • R&D experience preferred, but would take Operations / Manufacturing experience if it's in design control related activities (not looking for an ME)
  • Experience with generating risk analysis documents, familiarity with ISO 14971 preferred
  • Understanding of a medical device company's complaint process, FDA and ISO requirements on complaints
  • Statistical analysis skills, specifically trending and analysis, pareto charts, rate calculations (events / shipments)
  • Use of MiniTab a plus
  • Office skills required, specifically Word, and excellent writing skills
  • Solidworks experience a plus
Start date
07/2014
Duration
3 months+
(extension possible)
From
Real Staffing
Published at
23.07.2014
Project ID:
746186
Contract type
Freelance
To apply to this project you must log in.
Register