Complaint Evaluation Engineer

1 week ago


Rancho Santa Margarita, California, United States Applied Medical Full time
About the Role

Applied Medical is a leading medical device company that values innovation and excellence. We are seeking a highly skilled Complaint Evaluation Engineer to join our team.

Key Responsibilities
  • Evaluate the performance of products returned by customers
  • Perform device analysis in accordance with model-specific procedures and protocols
  • Conduct root cause analysis to investigate alleged product deficiencies
  • Propose corrective/preventive actions as required
  • Compose detailed reports describing results from investigations
Requirements
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a similar engineering discipline
  • Minimum of one year of experience in the medical device field or other regulated industry
  • Effective problem-solving and troubleshooting skills
  • Proficient computer skills, including knowledge of spreadsheets and word processing
  • Possess excellent oral and written communication skills
Preferred Qualifications
  • Experience in conducting failure investigations, reliability testing, and performing failure analysis leading to root cause and corrective/preventive actions
  • Working knowledge of Food and Drug Administration (FDA) and International Organization for Standardization (ISO) regulations


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