Quality Engineer

Responsibilities

• Defines, characterizes and leads the implementation of new manufacturing processes.
• Assures engineering & validation principals are applied to manufacturing process design and sustainability.
• Develops manufacturing processes to be trouble free and ensure success every time targeting Zero Defects.
• Supports concurrent engineering efforts by participating in design development projects representing manufacturing / quality assurance and the customer.
• Designs, implements and documents procedures for manufacturing process control, process improvement, testing and inspection.
• Establishes and implements reporting metrics for monitoring manufacturing process effectiveness and to enable managers to make sound product / process quality decisions.
• Performs root-cause analysis and other problem-solving activities to identify corrective actions and process improvements utilizing Allied Systematic Tools (AST) and various quality tools including 3 Leg 5 Why.
• Establishes collection and analysis systems of statistical data to predict trends that will affect improvement of product and process quality and capabilities targeting CpK 1.67 normal/CpK 2.0 KpC.
• Analyzes customers’ product specifications to establish efficient, cost-effective requirements for ease of manufacture and reproducibility.
• Assists with equipment selection and drive implementation of new equipment.
• Performs necessary actions for process development and documentation to perform and achieve acceptable Customer PPAP/FAI submissions and approvals.
• Develops, Monitors and improves manufacturing process performance and risk mitigation.
• Participates in review process for customer purchase orders, contracts and change requests and ensure that the necessary criteria and provisions are included in manufacturing process and quality plans.
• Interacts with customers to identify opportunities to improve quality and establish feedback with solution center and technical unit personnel.
• Reports Key Performance Indicators (KPI’s), quality issues, trends and losses to site management/value stream team/Regional Quality Manager.

Requirements

• Bachelor’s degree in a discipline of engineering, or other related field.
• In lieu of a degree, equivalent years of experience is required.
• 2 - 8 years of related work experience necessary.
• Working understanding of GMP, ISO9000, and AS9100 required.
• Experience in mechanical, process or product engineering and with automation of a manufacturing environment is preferred.
• Excellent communication skills including presentations to external parties, internal leadership and facilitating training.
• Must be able to relate technical information to non-technical employees.
• 6 sigma and/or lean manufacturing training a plus.

Physical Demands

• Predominately office-based but may spend considerable time standing and walking on the production floor or development lab.
• May be required to operate a computer as well as some production machinery and lab equipment.
• Occasionally may have to lift and/or transport items weighing between 10 and 40 pounds.

Work Environment

• Predominately office environment with occasional exposure to the production floor and development lab.
• While on the production floor, employee may be subjected to moving mechanical parts and may be required to put on precautionary, protective wear such as safety glasses.
• Some travel required.