Senior Software Quality Engineer in BD's Connectivity team responsible for test automation development and quality assurance. Collaborating to enhance V&V testing processes and compliance standards in medical technology.
About the role
- 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
- Strong interpersonal, and communication skills
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