System Quality Assurance Engineer


Morrisville, NC

Industry: IT Consulting/Services


Not Specified years

Posted 318 days ago

  by    Cynet EngineeringTeam

We are looking for ??System Quality Assurance Engineer for our client in Morrisville, NC

Job Title: ??System Quality Assurance Engineer

Job Location: Morrisville, NC

Job Type: Contract – 12 Months / Contract to Hire / Direct Hire

Job Description:

  • Actively contribute to Change Review Board as part of change control process.
  • Ensure compliance to regulatory requirements. 
  • Uphold quality system. 
  • Support internal and external audits.
  • Work in a cross-functional team environment including members from Manufacturing, Clinical, Regulatory, and Marketing.
  • Serve as quality representative for New Product Development. 
  • Contribute to requirements definitions and ensure that reliability, quality, and safety requirements are met. 
  • Work closely with Engineering to develop test protocols and reports
  • Develop, implement, and monitor various quality metrics. 
  • Identify opportunities for continuous improvement and customer satisfaction.
  • Compile and represent data for monthly CAPA Review and Product Review meetings, as well as annual reports.
  • Gather and analyze data for root cause analysis. 
  • Coordinate and drive efforts to assure CAPAs are opened and completed appropriately. 
  • Work with Engineering and Manufacturing to develop and implement corrective actions.
  • Support complaint sample evaluations and investigations. 
  • Track complaint data to identify actionable trends. 
  • Respond to customer and regulatory inquiries. 
  • Perform risk assessments and analysis. 
  • Participate in risk management meetings.