Quality Assurance Specialist

2 weeks ago


Andover, Massachusetts, United States TransMedics, Inc. Full time
Job Title: Quality System Engineer

TransMedics, Inc. is a leading innovator in organ care, revolutionizing the field with its pioneering Organ Care System (OCS). We are seeking a highly skilled Quality System Engineer to join our team, focusing on complaint handling, post-market surveillance, and process improvement initiatives.

Key Responsibilities:
  • Lead the Complaint Handling Unit, ensuring prompt resolution of customer complaints and maintaining excellent working knowledge of company products.
  • Investigate complaints to determine root causes, communicate with internal groups as needed, and review complaints to determine regulatory authority reporting and/or assessment.
  • Contribute to post-market surveillance efforts by collecting and managing relevant information, maintaining databases, and assisting in documentation for regulatory reporting.
  • Drive process improvement initiatives for enhanced field action readiness, involving internal documentation reviews and effective communication with regulatory authorities.
  • Apply risk assessment principles according to ISO 14971 to make informed decisions related to our processes and products.
Requirements:
  • Bachelor's degree in Mechanical, Electrical, or Biomedical Engineering, scientific, or related discipline.
  • Minimum of 3 years' experience in Quality Assurance, Quality Engineering, Manufacturing Engineering, or other related field in medical device/IVD industry.
  • Demonstrate proficiency in handling customer complaints, medical device reporting, and post-market surveillance activities.
  • Comfortable working in biosafety environment (BSL-2).
  • Experience with manufacturing environment preferred.
  • Ability to communicate ideas and information clearly, effectively, and concisely.
Education:

BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline



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