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Quality Engineer
Ref No.: 18-22524
Location: Raynham, Massachusetts
Position Type:Contract
Experience Level: 6 Years
Start Date: 04/04/2018
 
  • Utilize statistical tools and appropriate investigative techniques to analyze complaint root cause and corrective actions
  • Ensure complaint investigations are robust and well documented
  • File MDR and MDV reports as necessary to health authorities such as FDA
  • Escalate events in a timely manner and per procedure
  • Ensure key department metrics (such as complaint closure and health authority reporting timeliness) are met
  • Summarize the results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management
  • Support such activities as post market surveillance, complaint reports and safety signal detection
  • Support the CAPA process as necessary
  • Interface with key business partners including research and development, regulatory and compliance, operations, service and repair, medical affairs, medical safety, post market surveillance and international affiliates as required