Sw Product Quality Engineer

Philips UK

Onsite
Iec 62304 software standards knowledge
Iso 14971 risk management application
Design control and verification experience
This role is accountable for enabling Quality in Design across MR software products throughout the full lifecycle

Job Summary

  • This role is accountable for enabling Quality in Design across MR software products throughout the full lifecycle.
  • The position requires hands-on support to ensure design controls, risk management, and quality planning deliver safe and compliant software.
  • Candidates must possess strong communication skills to articulate technical topics to diverse stakeholders and influence without direct authority.

Matching Summary

This role is accountable for enabling Quality in Design across MR software products throughout the full lifecycle.

Skills & Requirements

Must-have

  • IEC 62304 software standards knowledge
  • ISO 14971 risk management application
  • Design control and verification experience
  • Regulatory compliance in medical devices
  • Software FMEA and hazard analysis

Nice-to-have

  • Agile development practices in regulated environment
  • Strong stakeholder management skills
  • Cross-site global team collaboration
  • Data analytics for quality trends
  • Intelligent analytics usage

Key Requirements

  • Bachelor's degree with 8-12 years experience or Master's with 6-10 years
  • Experience in regulated industry such as medical devices
  • Working knowledge of 21 CFR 820 and ISO 13485

Work Rights

Not specified

Tailored Resume

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