Reports to: Director of Quality Engineering

TechDevice Corporation is a growing medical device company that specializes in the design, development and contract manufacture/assembly of a broad range of Guidewires, Balloons and Balloon Catheter Assemblies. This includes products with 510(k) clearance for OEM's. TechDevice is also involved with the development of a variety of new proprietary product lines.

Job purpose:

The position of Quality Engineer is to be involved with all aspects of the quality program for TechDevice Corporation.  The quality program aspects are, but not limited to:

• FDA GMP Compliance
  
• ISO 13485 Compliance
  
• TechDevice Corporation’s Quality Policy Manual compliance
  
• Quality engineering as it relates to:
  
  
  
  • New Product Developments
    
  • Manufacturing
    
  • Cost Improvement Initiatives
    
  • Documentation Control

Responsibilities:    

The Quality Engineer will be responsible as the active lead for all initiatives and programs for TechDevice with regard to quality, documentation control and compliance.  This position will drive system oriented programs through development and initiation, review and modify existing programs with regard to current and proposed state, federal and international regulations.  Will develop Quality Programs for the development of new products and review and modify when necessary, existing quality plans for existing products.  Incorporated into these programs are subsets such as:

• Supplier Management
  
• Internal Auditing
  
• Corrective and Preventive Actions
  
• Customer Complaints
  
• Validations
  
• Discrepant Material Analysis
  
• Quality Records 
  
• Risk Analysis
  
• Incoming/In process/Final Inspection
  
• Research and Development Engineering
  
• Documentation Control

Qualifications:       

• 5 years minimum experience in a related regulated industry. Bachelor of Science Degree preferred.
  
• ASQ Certification in Quality Engineering, Auditing preferred.
  
• Computer proficient in Statistical analysis and AutoCad or Solidworks.