Quality Assurance Engineer I_GEJP00001717
Software Specialists - Totowa, NJ

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Description:
The Product Surveillance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Product Surveillance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.

Key responsibilities include:
  • Key contributor as part of a complaint handling unit
  • Developing and implementing methods and procedures for effective trending of complaints
  • Facilitating complaint investigation
  • Engaging product design owners to determine effective CAPA
  • Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
  • Reviewing appropriate criteria for closure of complaints
  • Owning and communicating metrics on status
  • Continuously working to improve the process
Qualifications:
  • Bachelor's degree in Engineering (Quality or related technical discipline) and 3-7 years' work experience in Quality or Regulatory Assurance related field
  • Minimum 3 years recent work experience in biomedical, electrical, mechanical or software product development and design.

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