Quality Engineer (in R&D)

Job Description:

  1. Responsible for quality assurance, monitoring, and coordination and tracking of design and development defects in the design and development process, and driving quality improvement in the R&D process;
  2. Supervises product compliance in the design and development process throughout the full life-cycle;
  3. Participates in the design review, design verification and design confirmation process of new products, and assists in data collection, reduction, statistics and analysis in the product R&D process;
  4. Establishes, maintains and continuously improves the quality management system (in the design and development module), and ensures its compliance with regulatory requirements;
  5. Formulates and improves the incoming, process, finished goods and outgoing inspection procedures (including standard samples and boundary samples when necessary);
  6. Identifies product performance requirements and establishes new test methods, and introduces measuring equipment;
  7. Assists in the R&D risk management activities.

Job Requirements:

  1. Has specialized knowledge in the design and development system of medical device industry, familiar with risk management activities;
  2. Has experience in introducing medical device suppliers, familiar with regulatory requirements on supplier management;
  3. Understands relatively complex mechanical drawings, capable of using quality tools.

Preferred Abilities

  1. Work experience in the medical device, electronics and automobile industries preferred;
  2. A certificate of ISO13485 Internal Auditor preferred;
  3. Good communication, organization, coordination and adaptation skills, and excellent stability preferred.
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