Advanced Engineer DQA

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.