DQA Engineer, NPI & Quality Systems Leader

Medline; Shanghai (VA); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline is seeking a quality-focused professional to lead project management and product development, collaborating with R&D and PM teams to define testing strategies that minimize failures during new product introductions. You will establish standardized methods for process control, validation, and inspection to ensure product quality and functionality.

The role involves designing and executing experimental testing and data analysis to drive data-driven decisions using statistical quality

Qualifications

• Experience leading cross-functional teams (R&D, PM, RA) in quality-focused projects.
• Strong knowledge of Design Control and Risk Management in product development.
• Experience with CAPA/SCAR and supplier quality improvements.
• Ability to analyze data using statistical quality tools to drive decisions.

Responsibilities

• Own project management and product development with cross-functional teams to define testing strategies.
• Develop and implement standardized methods for process control and validation.
• Design and execute testing programs and data analysis to reduce defects.
• Collaborate with suppliers and US stakeholders to resolve customer complaints and drive supplier quality.
• Ensure compliance, final release risk acceptance for NCMR and deviation processes.
• Maintain compliant product documentation and support regulatory submissions.
• Coordinate product testing with internal and external labs.

Skills

Project management

Cross-functional collaboration

Testing strategy development

Data-driven decision making

Quality systems

CAPA/SCAR implementation

Regulatory awareness

Job description

Medline is seeking a quality-focused professional to lead project management and product development, collaborating with R&D and PM teams to define testing strategies that minimize failures during new product introductions. You will establish standardized methods for process control, validation, and inspection to ensure product quality and functionality.

The role involves designing and executing experimental testing and data analysis to drive data-driven decisions using statistical quality