Senior Quality Engineer

Job Description

• Lead MRB sessions with cross-functional teams to determine disposition decisions and corrective action plans for non-conforming materials.
• Investigate customer complaints, field returns, and internal quality issues to identify root causes and implement corrective actions.
• Coordinate part replacement, screening, and containment activities at customer sites, third-party providers, and warehouse inventory.
• Perform RMA analysis and investigations, including SAP transactions and quality documentation (e.g., CoC requests).
• Review and maintain QA checklists, Work Instructions (WI), SOPs, inspection standards, and other quality documents.
• Prepare deviation requests, supplier change notifications, and support change management activities, including change notices and PCP updates.
• Work closely with Production, Engineering, Project, SQE, CQE, and fabrication teams to resolve quality issues and drive continuous improvement.
• Provide quality feedback and training to assembly technicians to ensure compliance with quality standards and procedures.
• Follow up with responsible parties to ensure timely closure of RMRs, investigations, and quality reports.
• Compile and analyze monthly quality metrics, including OLAR data and supplier rejection performance.
• Monitor, measure, and improve product and process quality performance to enhance customer satisfaction.

Job Requirement

• Knowledge of ISO 9001. ISO 13485, and ISO 14971 will be an advantage.

• Familiar with quality problem-solving methodologies such as CAPA, 8D, FMEA, 5 Why, and Fishbone Analysis.

• Knowledge of customer complaint handling, nonconformance control, and corrective action processes.

• Familiar with FAI, SPC, MSA, Control Plan, PFMEA, and other core quality engineering tools.

• Able to interpret drawings, specifications, critical requirements, and acceptance criteria.

• Knowledge of audit handling, risk assessment, change management, and continuous improvement practices