Design Quality Engineer responsible for comprehensive software quality documentation and compliance with regulatory standards at Philips. Leading assessments and validations of software design inputs for quality assurance.
Responsibilities
Facilitates the development, maintenance, and management of comprehensive software quality documentation
Leads the assessment of software designs, including reviewing test and performance data
Conducts in-depth root cause analysis for software quality issues
Validates key software design inputs such as usability, reliability, performance, localizability, safety, privacy, and cost
Provides effective oversight of the execution of software quality plans and associated risk management activities
Requirements
Bachelor's / Master's Degree in Computer Science or equivalent
3+ years of experience with Bachelor's in areas such as Software Quality Engineering, Design Quality Management, CAPA Methodologies, Product Quality
Experience in applying 21 CFR 820, ISO 13485, IEC 14971 and IEC 62304
Working knowledge with IEC 60601 and other relevant medical device standards
Must be able to successfully perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation
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