Systems Design Quality Engineer-medical

Philips UK

Medical device supplier assessment
Design control process management
Root cause analysis and capa
This role involves assessing medical device suppliers and ensuring global regulatory compliance for product safety

Job Summary

  • This role involves assessing medical device suppliers and ensuring global regulatory compliance for product safety.
  • The engineer will manage the entire design control process from input elicitation to verification and validation.
  • Candidates are expected to integrate quality, reliability, and post-market surveillance insights to drive continuous product enhancement.

Matching Summary

This role involves assessing medical device suppliers and ensuring global regulatory compliance for product safety.

Skills & Requirements

Must-have

  • Medical device supplier assessment
  • Design control process management
  • Root cause analysis and CAPA
  • Regulatory compliance adherence
  • Product safety risk assessment

Nice-to-have

  • Six Sigma Green Belt certification
  • ISO13485 certification experience
  • Post market surveillance insights
  • Continuous improvement techniques
  • Stakeholder mentorship skills

Key Requirements

  • Bachelor's or Master's degree in Engineering or Science
  • Minimum 5 years of experience in Quality Design Engineering
  • Minimum 2 years experience with Global Medical Device Regulations
  • Experience with ISO13485 certification preferred
  • Six Sigma Green Belt certification preferred

Work Rights

Not specified

Tailored Resume

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