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Quality Engineer
Ref No.: 18-24517
Location: Youngsville, North Carolina
Position Type:Direct Placement
Experience Level: 3 Years
Pay Rate : $ 75,000.00 - 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
Quality Engineer – Wake Forest/Youngsville, NC area
On-Board PMO is hiring a full-time Quality Engineer in the Wake Forest/Youngsville, NC area. You will be responsible for developing and maintenance of production quality standards and procedures, assisting the QA Manager in the maintenance of the Quality Management System, and assuring compliance with Quality System Procedures through the support of QA personnel.
  • Develops and maintains verification and inspection procedures, methods, and sampling plans to assure proper implementation of customer requirements and product specifications; performs inspections
  • Assists QA Specialists in the nonconforming materials control process by assuring non-conformances are identified, controlled, documented, resolved and closed in a proper and timely manner; writes reports
  • Develops and maintains training modules and training effectiveness assessments related to quality procedures and practices; trains manufacturing employees as needed
  • 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
  • Supports other departments in formulating and establishing procedures and practices which support the company quality objectives
  • 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
  • Facilitate Risk Assessment and Validation Activities     
  • Compiles and analyses performance reports and process control statistics
  • Develop Quality Assurance training materials
  • Communicate with internal and external customers in regards to quality control issues
  • Identify and evaluate cost savings with Management Team to uncover and opportunities
Education and Experience:
  • Bachelor’s Degree or higher (preferably in an engineering field)
  • Proficient in interpretation of regulatory requirements and standards
  • Experience in the performance of supplier audits / evaluations (highly preferred)
  • 3+ years of relevant quality engineering experience (i.e. manufacturing setting)
  • Experience with medical device manufacturing is preferred
  • Demonstrated success with using Quality Management tools and software
  • ASQ certification (highly preferred)
  • Advanced Microsoft Office (Word, Excel, Access, etc.) skills
  • Strong technical aptitude, including proficiency in reading and interpreting blueprints/drawings
  • Excellent analytical skills (cause and effect analysis)
  • Excellent written and verbal communication skills
  • Strong leadership skills