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Senior Quality Systems Engineer

4 weeks ago

Andover, Massachusetts, United States TransMedics Full time
{"Job Title: Senior Quality Systems Engineer TransMedics, Inc., a pioneering company in organ care, is seeking a dynamic individual to join our Quality team. Key Responsibilities:
  • Manage complaint handling, post-market surveillance, and process improvement initiatives.
  • Lead investigation activities to determine root causes and communicate with internal groups as needed.
  • Contribute to post-market surveillance efforts by collecting and managing relevant information.
  • Drive process improvement initiatives for enhanced field action readiness.
  • Collaborate closely with Regulatory Affairs, Operation, Service, and Quality Assurance teams.
Requirements:
  • Bachelor's degree in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.
  • Minimum of 3 years' experience in a 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.
TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees. "}