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Quality Engineer

2 months ago


Marlborough, United States G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing) Full time

Our client in Marlboro, MA is looking to bring on a Quality Engineer. This is a direct hire opportunity.


Responsibilities:


  • Support new product development, design changes to existing products, and process development to support development. Participate in the risk management process. Develop and validate new test methods, to include performing product testing. Determine sample sizes needed to verify and validate new products and processes.
  • Support manufacturing activities to continually improve product quality. Develop and implement inspection procedures. Participate in the disposition of non-conforming material and the investigation into root causes and implementation of corrective and preventive actions.
  • Support incoming, in-process, and final inspections of components and finished goods. Maintains the procedures, policies and systems needed to meet the requirements of the Company’s Inspection System. Manages maintenance and archival storage of incoming records and documents.
  • Support complaint handling process with assistance in determination of root cause of confirmed complaints, and work with other functions to determine and implement corrective actions. Draft and author complaint response communication to customers for completed complaint investigations.


Experience:


  • 8+ years as a Quality Engineer working in a medical device setting.
  • Bachelors Degree is preferred.
  • Catheter experience, with Class 3 electrophysiology devices a strong plus.
  • Applied knowledge of statistics and statistical techniques.
  • Understanding of design and process control requirements for US and international product distribution.
  • Experience working with medical devices.