Systems Design Quality Engineer-medical

Philips

Not specified; not specified; not specified
Medical device design control process
Statistical tools for process validation
Root cause analysis and capa execution
This role assesses medical device suppliers and ensures global regulatory compliance while managing the entire design control process from input elicitation to design transfer

Job Summary

  • This role assesses medical device suppliers and ensures global regulatory compliance while managing the entire design control process from input elicitation to design transfer.
  • The engineer creates comprehensive process validation strategies using statistical tools to ensure seamless new product transitions while maintaining rigorous adherence to safety standards.
  • Candidates will guide risk management activities and leverage post-market performance data to drive continuous enhancement of product quality and reliability.

Matching Summary

This role assesses medical device suppliers and ensures global regulatory compliance while managing the entire design control process from input elicitation to design transfer.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Medical device design control process
  • Statistical tools for process validation
  • Root cause analysis and CAPA execution
  • Risk management throughout product lifecycle
  • Design verification and validation planning

Nice-to-have

  • Six Sigma Green Belt certification
  • ISO13485 supplier audit experience
  • Post-market surveillance insights integration
  • Continuous improvement techniques application
  • Stakeholder mentorship and guidance

Key Requirements

  • Bachelor's or Master's degree in Engineering or Science
  • Minimum 5 years experience in Quality Design Engineering or R&D
  • 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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