Advanced Engineer DQA Job Shanghai Virginia USA,Quality Assurance

Location: Shanghai

Take ownership of project management and product development, collaborating with cross-functional teams (R&D, PM) to define appropriate testing strategies and minimize product failures during new product introduction (NPI).
Develop, approve and implement standardized methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure product quality and functionality.
Design and execute experimental testing and data analysis to maintain quality performance, minimize defects and failure rates, and drive data-driven decision-making using statistical quality tools.
Collaborate with suppliers and key stakeholders (US R&D, US PM, US RA, Sourcing, SQE, QE, QC, etc.) to resolve customer complaints, ensure effective implementation of CAPA/SCAR, and drive continuous supplier quality improvement.
Ensuring quality decision making, compliance, and final release risk acceptance for both NCMR and Deviation processes.
Identify and drive product and process improvement opportunities with suppliers to enhance quality performance and achieve cost efficiencies.
Manage and oversee supplier-initiated change requests, ensuring changes are properly evaluated, validated, and implemented in compliance with quality and regulatory requirements
Establish and maintain compliant product documentation (e.g., Device Master Records, technical files) and collaborate with Regulatory Affairs and suppliers to support regulatory submissions (e.g., 510(k), Letter to File).
Provide expertise in product development, including Design Control, Risk Management, and compliance with applicable technical documentation requirements (e.g., CE Technical Files).
Conduct thorough quality reviews of design and development documentation to ensure compliance with internal standards, regulatory requirements, and supplier quality documentation.
Drive continuous communication and alignment with suppliers to ensure clear understanding and adherence to internal standards, regulatory requirements, and quality expectations.
Coordinate product testing activities with internal and external laboratories to ensure timely and accurate execution of qualification and validation testing.

Job Summary

Job Description

Take ownership of project management and product development, collaborating with cross-functional teams (R&D, PM) to define appropriate testing strategies and minimize product failures during new product introduction (NPI).
Develop, approve and implement standardized methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure product quality and functionality.
Design and execute experimental testing and data analysis to maintain quality performance, minimize defects and failure rates, and drive data-driven decision-making using statistical quality tools.
Collaborate with suppliers and key stakeholders (US R&D, US PM, US RA, Sourcing, SQE, QE, QC, etc.) to resolve customer complaints, ensure effective implementation of CAPA/SCAR, and drive continuous supplier quality improvement.
Ensuring quality decision making, compliance, and final release risk acceptance for both NCMR and Deviation processes.
Identify and drive product and process improvement opportunities with suppliers to enhance quality performance and achieve cost efficiencies.
Manage and oversee supplier-initiated change requests, ensuring changes are properly evaluated, validated, and implemented in compliance with quality and regulatory requirements
Establish and maintain compliant product documentation (e.g., Device Master Records, technical files) and collaborate with Regulatory Affairs and suppliers to support regulatory submissions (e.g., 510(k), Letter to File).
Provide expertise in product development, including Design Control, Risk Management, and compliance with applicable technical documentation requirements (e.g., CE Technical Files).
Conduct thorough quality reviews of design and development documentation to ensure compliance with internal standards, regulatory requirements, and supplier quality documentation.
Drive continuous communication and alignment with suppliers to ensure clear…