| Spellman High Voltage Electronics Corporation is the world’s leading manufacturer of high voltage power supply, X-Ray generator and Monoblock® X-Ray sources. Our products power medical diagnostic imaging, scientific research equipment, airline security systems, food and consumer product scanners, and intercontinental communications. Spellman’s power sources enable the improvement, and saving, of lives.
SUMMARY
The Lead Quality Engineer is responsible for supporting a wide variety of manufacturing, supplier, engineering, and customer quality issues. Primary interface across all aspects of the organization for customer quality issues. RESPONSIBILITIES - Identify factory yield or process issues and drive improvements including data analysis, updating/improving Control Plans on PFMEA, improving processes & procedures.
- Analyze all aspects of the product from sales to product development to NPI to supply chain to manufacturing to service to all other aspects of the product to determine if improvements are needed.
- Provide timely and concise communication and escalation of issues to quality and operations teams and to other relevant departments. This includes, but is not limited to, project plans, action registers, weekly activity reports, monthly and quarterly updates, and other updates as needed.
- Perform strategic planning to determine longer range needs and process improvements using high level, with some detail, strategic plans developed to support and exceed corporate goals for product quality & reliability, manufacturing yields, Cost Of Poor Quality, and other metrics.
- Proactive engagement with and response to Engineering, Operations and Sales
- Provide Quality support to Product Development for design control and verification/validation to drive Quality Improvement by actively participating in Design Reviews – phase gate methodology, driving and promoting quality in the design through utilization of reliability data, component data, supplier quality data, and reliability testing.
- Drive Corrective Action/Preventative Action (CAPA) activities using core quality tools to ensure proper identification of causal factors and/or true root cause and to develop solid corrective action that will ensure this issue does not reoccur.
- Work with operations to support problem resolution as needed with respect to proper methodologies and instructions to correctly perform rework or ‘out-of-routing’ operations.
- Conduct training, process audits, product audits to ensure personnel are properly trained and carrying out defined processes & procedures and that control plans are effective.
- Address actual and potential Quality and Regulatory Issues. Revise work instructions and quality documents as required.
- Actively participate in the New Product Introduction process through the development & implementation of elements of APQP such as FMEA, PPAP, Control Plans, Gauge R & R, Failure Analysis, Process Controls, and Data Analysis.
- Ensure customer satisfaction by monitoring customer complaints, customer returns, and other customer related issues, creating CAPA for each issue, ensuring identification of true root cause and implementation of effective corrective actions.
- Actively participate in Supplier and Customer business reviews. Prepare quality data ahead of time, assist in development of standard quality presentation and prepare this material for review with customers and/or suppliers, present the material and take away action items as necessary.
- Evaluate and rollout “Best Practices” while driving systems and process-based organization.
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