Quality Engineer II

Overview

Quality Engineer II is responsible for maintaining the assigned business units' quality management system in accordance with relevant standards and cGMP (Good Manufacturing Practices) and drives continuous improvement to meet the performance objectives of the business. The quality engineer drives improvement through effective collection, analysis and reporting on trends or isolated events. As this is supporting an FDA regulated business, this role also assures QMS, and process streams meet regulatory requirements including cGMP (Good Manufacturing Practices).

The Quality Engineer II will report to the Healthcare Global Quality Manager and be supported by the E&I Quality Network.

Your Key Responsibilities

• Lead and / or participate in root cause investigation of internal and external (customer complaints) quality non-conformances and determine appropriate corrective action by using tools such as 5 Why, FMEA's, Root Cause Analysis, etc. and ensure actions are effective.
• Utilize appropriate business protocol (Product Change Management, Test Authorization, Change of Design), develop, and implement quality related plant improvements, lead raw material, and finished product qualifications.
• Identify and perform corrective and preventative actions related to quality management system improvement, customer satisfaction, quality related aspects of supplier, manufacturing, and contract manufacturing.
• Effectively use Failure Mode Effect Analysis (FMEA) to anticipate failure modes, design detections and controls to prevent unplanned events and drive improvement.
• Perform statistical analysis of property data and assess the capability to meet customer specifications and act when a risk of non-conformance is identified.
• Control and disposition of non-standard production.
• Lead production improvement projects
• Coordinate customer complaint responses to customer or marketing / sales requests relating to quality information or issues.
• Initiate, monitor, and execute quality improvement programs / events, to align with and achieve COTs (Critical Operating Tasks) or area goals.
• Support or lead manufacturing in maintaining document control such as Standard Practice, Standard Operating Procedures, Check sheets, Tests, etc.

Qualifications

DuPont is an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class. If you need a reasonable accommodation to search or apply for a position, please visit our Accessibility Page for Contact Information.

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