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Quality Assurance Engineer
Ref No.: 18-01675
Location: Youngsville, North Carolina
Position Type:Direct Placement
Experience Level: 3 Years
Pay Rate : $ 65,000.00 - 85,000.00 /Year
Shift Comments:Monday thru Friday 8am to 5pm
Job Category:Manufacturing/Operations
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, Vision Insurance
On-Board PMO is hiring a Quality Assurance Engineer in the Youngsville, NC area. You will be responsible for assuring compliance by developing and maintaining quality standards of production and procedures.

Key Responsibilities:
  • Develop quality related processes and initiatives
  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet and exceed internal and external requirements
  • Facilitate Risk Assessment and Validation Activities
  • Perform and document investigations, establish effective corrective action plans, and follow-up after CAPA plans have been implemented
  • Perform internal and external audits to maintain compliance
  • Compiles and analyses performance reports and process control statistics
  • Develop Quality Assurance training materials
  • Ensure that personnel is trained and that the training is documented
  • Communicate with internal and external customers in regards to quality control issues
  • Work together with Engineers and Management Team to uncover and evaluate cost savings opportunities
  • Other duties as assigned
Education and Experience:
  • Bachelor's Degree or higher (preferably in a technical field)
  • ISO & ASQ certifications preferred
  • 3+ years of relevant quality assurance experience (i.e. manufacturing setting)
  • Experience with medical device manufacturing is preferred
  • Proficiency in regulatory requirements and standards
  • Experience with using Quality Management & Statistical tools and software
  • Advanced Microsoft Office (Word, Excel, Access, etc.) skills
  • Demonstrates excellent analytical skills
  • Excellent written and verbal communication skills