Quality Engineer II

Responsibilities

• Creates, revises, and implements quality standards as well as procedures (i.e., Standard Operating Procedures (SOPs), etc.) in accordance with established Erbe Quality system.
• Implement and evaluate changes to existing processes designed to improve product quality, productivity and overall equipment efficiency.
• Develop and maintain process documentation ensuring that processes and procedures are clearly stated and understandable for all employees.
• Provide technical support/solutions to manufacturing processes, improve yield and throughput, drive cost reduction activities and improve on part quality.
• Demonstrated ability to start-up, operate and shut down process related equipment. Must be able to work independently on new process development as well as troubleshooting current production issues.
• Monitor and report issues with tooling, make recommendations for refurbishment based on production factors such as cycles, process capability and tooling history.
• Interact with stakeholders to resolve issues and provide project updates.
• Implement technical solutions including statistical methodology to meet cost, quality, and delivery expectations.
• External and internal Supplier Quality experience.
• Author validation documents and records including IQ, OQ and PQ reports and protocols.
• Drive Design Control Processes including Verification and Validation Activities
• Test Method Development
• Conduct Risk Management and FMEA activities, ensuring risks are identified, evaluated, mitigated, and documented per ISO
  14971 and related standards
• Work with Design files including drawings, specifications and records.
• Collaborate cross-functionally with Engineering, Manufacturing, materials management, and other functional groups to ensure product transfer, regulatory compliance, and quality integration
• Evaluates and establishes controls for all suppliers/vendors who have an impact on product quality; conducts initial assessments as well as yearly performance reviews to convey and resolve quality issues as they arise.
• Reviews testing methodologies, equipment, documentation, etc. for appropriateness to demonstrate that conformance to established standards and/or specifications.
• Reviews product and system failures to determine root causes with recommendations for corrective/preventive measures. Identifies preventive actions to minimize/eliminate potential problems. Verifies implementation and effectiveness of solutions to quality related issues.
• All other duties as assigned by the Quality Manager.

• Creates, revises, and implements quality standards as well as procedures (i.e., Standard Operating Procedures (SOPs), etc.) in accordance with established Erbe Quality system.
• Implement and evaluate changes to existing processes designed to improve product quality, productivity and overall equipment efficiency.
• Develop and maintain process documentation ensuring that processes and procedures are clearly stated and understandable for all employees.
• Provide technical support/solutions to manufacturing processes, improve yield and throughput, drive cost reduction activities and improve on part quality.
• Demonstrated ability to start-up, operate and shut down process related equipment. Must be able to work independently on new process development as well as troubleshooting current production issues.
• Monitor and report issues with tooling, make recommendations for refurbishment based on production factors such as cycles, process capability and tooling history.
• Interact with stakeholders to resolve issues and provide project updates.
• Implement technical solutions including statistical methodology to meet cost, quality, and delivery expectations.
• External and internal Supplier Quality experience.
• Author validation documents and records including IQ, OQ and PQ reports and protocols.
• Drive Design Control Processes including Verification and Validation Activities
• Test Method Development
• Conduct Risk Management and FMEA activities, ensuring risks are identified, evaluated, mitigated, and documented per ISO
  14971 and related standards
• Work with Design files including drawings, specifications and records.
• Collaborate cross-functionally with Engineering, Manufacturing, materials management, and other functional groups to ensure product transfer, regulatory compliance, and quality integration
• Evaluates and establishes controls for all suppliers/vendors who have an impact on product quality; conducts initial assessments as well as yearly performance reviews to convey and resolve quality issues as they arise.
• Reviews testing methodologies, equipment, documentation, etc. for appropriateness to demonstrate that conformance to established standards and/or specifications.
• Reviews product and system failures to determine root causes with recommendations for corrective/preventive measures. Identifies preventive actions to minimize/eliminate potential problems. Verifies implementation and effectiveness of solutions to quality related issues.
• All other duties as…