Quality Engineer at Avive analyzing and reporting on product failures to improve safety and quality. Collaborating with multiple teams in a growing AED company.
Responsibilities
Perform failure analysis on electromechanical devices returned with alleged malfunctions utilizing design documentation, system log data, software tools, manufacturing lot records, and lab / bench equipment.
Generate complaint investigation reports, perform risk assessment and escalate any reportable and field safety issues.
Investigate internal nonconformances of components, assemblies, and manufacturing processes.
Collaborate with product development, software and manufacturing functions in analysis of product hardware and software failure modes.
Work with Customer Success team on creating troubleshooting guides, customer follow ups and communications related to alleged complaints and customer feedback.
Support development of methods and procedures for inspecting, testing and evaluating products.
Generate monthly complaint and nonconformances metrics and data analysis.
Support the quality processes for Management Review, Audits, CAPAs, and process improvements as needed.
Requirements
1 - 4 years of experience in engineering or technical role
BS in Engineering (preferably Electrical or Biomedical)
Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools
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