Advanced Engineer DQA

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

• 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 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.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.