Software Quality Engineer

@ Philips

Software Quality Engineer

The role ensures that appropriate Software Quality plans are created covering all software lifecycle stages and supports quality plan design. The candidate validates key design inputs including usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs.

Responsibilities include overseeing the execution of the Software Quality Plan, managing Risk Management activities during the software lifecycle, and leading quality-related problem solving. The candidate will use post-market analytics and statistics to report software performance, provide feedback to manufacturing, suppliers, or design teams, and initiate necessary field actions.

Act as a business partner and the single point of contact for project teams, ensuring that all software design quality requirements meet established SW Quality standards at every milestone.

You're the right fit if:

• Over 10+ years of industry experience in Product Quality Engineering.
• Experience in medical industry product development with strong SW quality expertise.
• Skilled in QMS 13485, 21 CFR, EU MDR, IEC 62304, IEC 62366, ISO 14971, and CAPA processes.
• B Tech in Computer Science or equivalent experience as a SW Developer.

Standards & Regulations:

ISO 13485, IEC 62304, ISO 14971, IEC 82304, IEC 62366-1, EUMDR, and 21CFR are key aspects of this role.

Work Arrangement & Company Culture:

This position is office-based with a requirement to work in-person at least 3 days per week. Philips is a global health technology company focused on improving healthcare globally through innovative technologies and meaningful collaboration.

Key skills/competency:

• Software Quality
• Risk Management
• Design Control
• Regulatory Compliance
• Medical Device Standards
• Post Market Surveillance
• QMS
• CAPA
• Audit Preparation
• Field Analytics