Design Quality Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Shanghai, China

Design Quality Engineer at Johnson & Johnson in Shanghai, China, focusing on the entire product life cycle of healthcare products. Responsibilities include quality engineering activities such as reliability, risk management, statistical techniques, requirements management, verification & validation, and design control. The role involves applying tools like Six Sigma and Lean, ensuring conformance to ISO, FDA & MDR quality systems, and acting as a technical liaison between development, manufacturing, and suppliers. Requires strong analytical and statistical problem-solving skills.

What you'd actually do

  1. Provide leadership in design & device implementation to support entire product life cycle of various products with focus on Quality Engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control.
  2. Apply tools and methods (for example: Six Sigma, Lean) to realize new product or process introductions as well as process and business improvements.
  3. Provide leadership and technical expertise to ensure conformance to ISO, FDA & MDR based quality systems.
  4. Review and approve the release of new products and design changes ensuring quality requirements are met.
  5. Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.

Skills

Required

  • Quality Engineering
  • Reliability
  • Risk Management
  • Statistical Techniques
  • Requirements Management
  • Verification & Validation
  • Design Control
  • Six Sigma
  • Lean
  • ISO
  • FDA
  • MDR
  • Analytical Problem-Solving
  • Statistical Applications (DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing)

What the JD emphasized

  • ISO
  • FDA
  • MDR