Responsibilities:

• Review technical documentation including SOPs, batch records, bills of materials and work instructions to ensure the compliance of ISO13485.
• Author Product Risk Process (PRP) Reviews. Collect, tabulate and analyze data for the reviews and author the reports based on the data evaluation. Ensure timely completion of the reviews.
• Perform product impact / risk assessments for non-conformances, CAPAs, etc.
• Improve quality of products by utilizing data/metrics to evaluate performance, identifying and responding to improvement opportunities.
• Liaise with the customers across the world with product registration.
• Product testing and data analysis for continuous improvement.
• Develop and implement analytic tools using advanced statistical analysis of quality data to enable analysis of product performance to facilitate continuous improvement opportunities.
• Support the Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Field Action, etc. Update risk management file documents as needed.
• Provide Quality support on project work and lead projects related to core production while ensuring compliance with Design Controls and applicable regulations/standards. Challenge the approach and provide innovative alternative solutions to identified challenges.
• Challenge conventional wisdom, demonstrate innovative thought, understand risks associated with decisions and develop possible solutions which mitigate risks.

Requirements:

• Bachelor’s degree required in Engineering or Science
• Minimum of 3 years of cGMP or ISO13485 related commercial manufacturing experience
• CAPA lifecycle experience, including root cause investigation
• Technical writing
• Presentation and communication skills
• Experience with process monitoring and statistical analysis of data
• Strong MS Office background (Excel, Access, Word, Project, PowerPoint, Visio, etc.)
• Strong project management, planning, organizational and communication skills desired
• Strong process improvement skills (process mapping, DMAIC etc.)
• Stay in Suzhou or Foshan for 2 weeks monthly.
  
• Essential Skills, Experience, and Competencies(includes Licenses, Credentials)
• Ability to train and motivate in area of compliance and quality improvement
• Self-motivated with ability to manage timely completion of long-term projects
• Ability to work in a collaborative team environment
• Ability to manage project priorities based on production needs