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Mid-level role in metro with Philips brand increases competition, tempered by regulatory/medical-device specialization.
Healthcare regulatory and medical-device quality focus makes skills less transferable across industries.
Mandatory 5–7 years plus regulatory and quality compliance requirements make screening strict.
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Maintain and update comprehensive software quality documentation ensuring compliance with relevant standards throughout the software lifecycle.
Conduct software design assessments and root cause analyses to embed quality, safety, and regulatory standards into software products.
Oversee execution of software quality plans, risk management, and post-market analytics to monitor and improve software quality continuously.
Bachelor's Degree in Computer Science, Computer Applications or equivalent/Vocational Education.
5-7 years of experience in Software Quality Engineering.
Working knowledge of global software regulatory requirements and standards.
Onsite role requiring full-time presence at company facilities.
Experienced in design quality management and software development lifecycle (SDLC) processes with focus on regulatory compliance.
Capable of applying root cause analysis, CAPA methodologies, and risk assessments related to privacy, safety, and security.
Skilled in technical documentation, data analysis, and leading quality engineering practices aligning with business and regulatory objectives.