Biomedical Engineer
3 weeks ago
Duties:
Candidates will work in a few aspects of our complaints handling system. Will work on complaint handelling.
Initially, will work in the lab assisting with returned product root cause investigation and evaluation submission.
May also be tasked with assisting complaint handling process: intake, processing, and reporting on product experiences.
May perform multiple functions within the postmarket surveillance department.
Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints.
Complete FDA MDR and other outside competent authority regulatory reports.
Skills:
Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred.
Required:
Associate required; Bachelors preferred.
Candidates with a technical background or a history of root cause analysis/failure analysis, electrical, miscellaneous lab or engineering tasks a plus.
Candidates with great organization skills, a history of understanding and complying with policy and procedures, medical device reporting, or customer service a plus.
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