QA Engineer

Job Detail

Plan and manage product quality, including product qualification and design validation. Create and maintain documentation such as the Acceptance Test Plan (ATP), Acceptance Test Record (ATR), Inspection Plan (IP), SOP, Work Instruction, Test Procedures, and Calibration Procedures. Participate and contribute to the New Product Introduction Process and understand specification development and verification upon transition to production. Participate and contribute to process or production yield improvement projects by applying statistical tools and Six Sigma methodology. Participate in the Material Review Board (MRB) and the disposition of internal nonconforming materials. Review product concession and deviation notices for adequacy and correctness prior to submission for customer approval. Manage Customer Returns through Return Materials Authorization (RMA) and coordinate with the cross-functional team to process and close cases with root cause analysis and corrective actions, and report monthly status. Analyze and report on Customer Quality Performance. Coordinate the site's Corrective and Preventive Action process relevant to customer complaints, including root cause analysis, verification of effectiveness, and closure of corrective and preventive actions. Assist in the training and maintenance of the site Quality Management System: AS9100, ISO9001, and any other applicable standards such as ISO13485 for Medical Devices. Support and participate in Certification Body and customer audits, and conduct internal and supplier audits. Support and participate in upgrading and enhancing measurement system capability. Lead and/or support groups of technicians or engineers in quality activities. Perform ad hoc tasks as required. Keep up to date with developments and trends in Quality Best Practices and Regulatory Standards. Communicate and work with suppliers to address material quality and documentation issues as reported by the Incoming QA and Production departments. Facilitate and/or participate in Material Review Board (MRB) meetings for the disposition of nonconforming materials, and/or meetings with relevant internal departments (R&D, Engineering, Sourcing, QA, Sales, Production, etc.) to address manufacturing issues or disputes relevant to supplier materials, documentation, and drawing specifications or requirements. Review and approve supplier records and reports including, but not limited to: First Article Inspection Reports, Specification Review Forms (SRF), SCAR, Control Plans, GRR, and Cpk Reports, where applicable. Participate in the Supplier Readiness Checklist and/or FAT meetings to support the Sourcing and Purchasing departments in communicating and flowing down customer-specific requirements to suppliers. Issue Supplier Containment Action Notices (SCAN) and Supplier Corrective Action Reports (SCAR) to suppliers, and follow up on supplier replies for review and closure. Provide guidance to suppliers to meet customer-specific requirements. Support the Incoming QA department in conducting measurement correlations with relevant internal departments and suppliers.