Hot Senior Quality Engineer Medical Device UT

Shore Consultants is the fastest growing most comprehensive Pharmaceutical /Medical Device Recruiting Firm within the MRI Network. Why?  We deliver over and over and over; one quality placement at a time. Come and see the ultimate standard in client and candidate satisfaction. Visit www.sceaston.com for client critical information and exciting new careers!!!

Our client is a medical device manufacturer involved with various treatment as well as multiple surgical specialties.  We are pleased to be involved in their search for Quality Assurance Engineer (Senior), located in beautiful Salt Lake area of UTAH! This position is responsible for design, develop and implemention new product processes, test methods and equipment as well as providing support for new product development teams This position is responsible for system development and improvement and project management. This is a priority fill position -if interested please forward word document resume, salary requirements and relocation considerations to [Click Here to Email Your Resumé]  IF not interested please forward to a colleague who might benefit from knowing about this exciting opportunity.

POSITION: Quality Engineer -Senior ??? UTAH

RESPONSIBILITIES:

• Develop Test Protocols, Final Reports, and support Regulatory (510(k), PMA) submissions
  
• Coordinate with design, manufacturing, regulatory and other team members.                    
  
• Develop DOE's, Design Verification Protocol, Final Design Verification Report, Gage R&R
  
• Implement/support design controls for development and launch of medical devices,
  
• Provide Quality Engineering support of New Product Development (NPD)
  
• Development of the PFMEA,DFMEA Process Validation Studies           
  
• Design and qualify inspection and test equipment. 
  
• Support CAPA Process (product/process non-conformances, customer complaints,  internal audits)
  
• Conducts complaints investigations
  
• MRB participation 
  
• Track and trend process improvements      
  
• Lead Quality Engineering Projects
  
• Maintains relationship with internal & external customer and support staff

REQUIREMENTS:

• Bachelor???s Degree (Engineering, Technical Sciences)
  
• 6 years min experience Quality, Manufacturing, or R&D (7-8 years engineering) Or  MS (Engineering, Technical Sciences) with 5 years
  
• 3  years proven and effective project management
  
• Engineering experiences with design controls, product/process validation medical device
  
• Competency in Quality Technology(statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability etc.)
  
• Knowledge of FDA QSR???s, ISO13485:2003, and ISO 9001:2000.
  
• Six Sigma/Process Skills 
  
• Excellent oral, written, interpersonal, leadership and computer skills.
  
• Demonstrated leadership skills
  
• Green Belt/Black Belt Certification a plus