Systems Design Quality Engineer-medical

Philips UK

Shenzhen, China
On-site
Design control process management
Process validation strategies
Risk management activities
Philips UK is seeking a Systems Design Quality Engineer in Shenzhen, China, to ensure regulatory compliance and product safety in medical devices. The role involves assessing suppliers, executing validation strategies, and managing design controls, requiring a Bachelor's/Master's degree and extensive experience in quality design engineering and medical device regulations

Job Summary

  • Assesses medical device suppliers, products, verification, product safety risk, and regulatory compliance for suitability and effectiveness in global markets.
  • Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer.
  • Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback and initiating corrective actions.

Matching Summary

Match Score: 85

Philips UK is seeking a Systems Design Quality Engineer in Shenzhen, China, to ensure regulatory compliance and product safety in medical devices. The role involves assessing suppliers, executing validation strategies, and managing design controls, requiring a Bachelor's/Master's degree and extensive experience in quality design engineering and medical device regulations.

Skills & Requirements

Must-have

  • Design control process management
  • Process validation strategies
  • Risk management activities
  • Post-market surveillance data analysis
  • Quality improvement projects

Nice-to-have

  • Continuous improvement techniques
  • Effective stakeholder relationships
  • Guidance and mentorship

Key Requirements

  • Bachelor's/Master's Degree in Engineering or Science
  • Minimum 5 years of experience in Quality Design Engineering
  • Minimum 2 years experience with Global product Medical Device Regulations

Work Rights

Not specified

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