Quality Engineer - Dayuan

The Quality Engineer is responsible for supplier and raw material quality management, compliance, risk mitigation, issue resolution, and audit support to ensure consistent product quality and customer satisfaction.

Key Responsibilities
Supplier Quality Management

• Develop, implement, and maintain supplier quality management programs to ensure suppliers consistently meet business, regulatory, and customer requirements.
• Lead supplier qualification, supplier performance monitoring, supplier audits, and ongoing supplier risk assessments.
• Drive supplier corrective and preventive actions (CAPA) for supplier-related quality issues and ensure timely closure of corrective actions.
• Manage supplier change notifications, process changes, raw material changes, site transfers, and Management of Change (MOC) activities to assess and mitigate quality risks.
• Establish and maintain supplier quality metrics, scorecards, and periodic performance reviews to drive continuous improvement.

Raw Material Quality Management

• Own the quality management process for raw materials, including specifications setup, new source qualification, incoming quality performance, and risk assessments.
• Ensure non-conforming raw materials and material returns are properly controlled, investigated, dispositioned, and prevented from unintended use.
• Lead investigations related to raw material quality issues, coordinate root cause analysis, and implement effective corrective actions with suppliers and internal stakeholders.
• Support strategic raw material risk management initiatives, including identification and mitigation of high-risk materials and development of alternative sources.
• Utilize quality data, supplier performance trends, complaint data, and process metrics to identify opportunities for quality improvement and risk reduction.

Product Quality Management

• Serve as the quality focal point and provide leadership in maintaining product quality, consistency, and compliance throughout the product lifecycle.
• Lead or support investigations of product quality incidents, customer complaints, out-of-specification results, and process deviations affecting products.
• Participate in cross-functional projects and change management activities that may impact product quality, including formulation changes, process changes, equipment modifications, and specification updates.
• Monitor product quality performance and recommend improvement initiatives to enhance process capability, product consistency, and customer satisfaction.

Customer Quality & Audit Support

• Act as an effective interface between customers, commercial teams, and manufacturing sites to ensure customer quality requirements are understood and fulfilled.
• Support customer audits, assessments, and visits by coordinating audit preparation, responding to audit observations, and ensuring timely closure of actions.
• Represent the Voice of the Customer within the organization and provide quality-related technical support for customer inquiries, qualifications, and special requirements.
• Participate in customer complaint management, including investigation, root cause analysis, corrective action implementation, and customer communication.

Quality System & Continuous Improvement

• Monitor the effectiveness of the Quality Management System (QMS) and identify opportunities for continuous improvement.
• Conduct internal audits, supplier audits, and contract manufacturer assessments, leveraging audit findings to improve quality performance.
• Train and provide guidance to internal teams, manufacturing personnel, laboratories, and suppliers on quality requirements, procedures, and best practices.
• Lead and support continuous improvement projects utilizing data-driven methodologies to improve supplier quality, raw material quality, product quality, and customer satisfaction.