Job Summary

A business to business service has an open position for a Remote Medical Device Quality Engineer.

Core Responsibilities Include:

• Participating as QA consultant in client facing projects
• Collecting and defining project requirements and develop solutions
• Advising clients on QE concepts, principles and practices as they relate to the companies solutions and products.

Required Skills:

• Bachelor's Degree in an engineering/ scientific discipline
• 3+ years of in-depth Quality System implementation in compliance with FDB, FDA, and ISO 13485
• 2+ years of multiple simultaneous project QA or client facing QA consultancy
• Experience with the R&D lifecycle with emphasis on the QA aspects
• Knowledge of statistics and application of statistical methods
• Experience using Microsoft Access, Word, Excel, PowerPoint, Microsoft Outlook and Solidworks