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Quality Engineer - Post Market Surveillance
Quality Engineer - Post Market SurveillanceGentuity, LLC • Sudbury, MA, US
Quality Engineer - Post Market Surveillance

Quality Engineer - Post Market Surveillance

Gentuity, LLC • Sudbury, MA, US
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SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES :

  • Manage Gentuity's complaint handling process ensuring compliance with regulatory standards and Gentuity's QMS.
  • Analyze and categorize complaints to develop metrics and identify trends and areas for improvement.
  • Collaborate with cross-functional teams to promptly investigate and resolve complaints.
  • Prepare and submit detailed reports on complaint investigations to Gentuity's internal and external customers.
  • Train team members in complaint management best practices.
  • Maintain accurate documentation of all complaint-related activities in Gentuity's eQMS system.
  • Supporting members of CAPA team aiding in investigation and root cause analysis.
  • Provide support for test method development used to determine robust complaint and CAPA root cause.
  • Support any Post Market Surveillance activities as required to maintain compliance per regulatory requirements.
  • Other duties as assigned

EXPERIENCE / SKILL REQUIREMENTS :

  • Time management skills
  • Microsoft Word, PowerPoint, Excel experience
  • Organization skills
  • 1 – 3 years, experience in a medical device or pharmaceutical environment.
  • Investigation experience related to product performance.
  • Previous experience with eQMS systems preferred.
  • EDUCATIONAL REQUIREMENTS :

  • Bachelor's Degree, in a Technical or Scientific / Engineering discipline preferred, OR an equivalent combination of Education and Work Experience.
  • Equivalence work experience, a minimum of 5 years work experience in medical device or pharmaceutical industry.
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    Quality Engineer • Sudbury, MA, US

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