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DuPont’s Healthcare Industries Materials Site in Hemlock, MI is searching for a talented, motivated, and enthusiastic Quality Engineer .

The Quality Engineer is responsible to maintain 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 thru the 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 will report to the Healthcare Global Quality Manager and be supported by the E&I Quality Network.

Your Key Responsibilities:

• Responsible for the unit’s quality management systems, ensuring alignment with overall site management systems and business management system. This includes updates to the unit’s quality manual, procedures and ensuring practices are in compliance with all applicable standards.

• Conduct first party and coordinate 2nd and 3rd party quality audits such as ISO, customer audits and monitors the corrective action plans.

• 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 performs 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 assesses 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.

• Monitor raw material and packaging supplier performance.

• Support or lead manufacturing in maintaining document control such as Standard Practice, Standard Operating Procedures, Check sheets, Tests, etc.

• Serve as a Subject Matter Expert (SME) resource for quality training, as needed, for new and existing employees. Serve as the SME and site resource for assuring compliance to cGMP standards.

Qualifications

• Bachelor’s degree in engineering, Chemistry, or related sciences.

• 5 years’ experience in a chemical manufacturing environment with processes certified to ISO9001, GMP, NSF, etc.

• Ability to understand the quality standards relevant to the industry requirements (e.g., ISO 9001:2015, GMP, NSF) and the controls necessary to achieve and maintain compliance with the standards as appropriate.

• Demonstrated ability to understand, calculate, establish, and communicate key quality metrics including complaints, complaint frequency, cycle time & audit results.

• Demonstrated experience and results in auditing, conducting root cause failure analysis and FMEA’s and identify and drive closure on critical corrective and preventive actions.

• Demonstrated understanding and experience in data analysis and its application to improve manufacturing process capability.

• Experience in process troubleshooting, operational quality SOP/SP knowledge, customer quality change management.

• Understanding of quality IT systems (LIMS, SAP, SPC) and tracking.

• Knowledge of the processes and flow in the operation as it relates to quality.

• Delivers clear and succinct oral and written messages and able to make complex messages clear both internally and to our customer.

• Demonstrated influential leadership skills as to drive quality improvements. Required competencies: bias for action, integrity, judgement, strong interpersonal and leadership skills, solid time management skills, change agent behavior, and superior communication skills.

• Root Cause Investigation training. Lead problem solving activities for significant quality incidents or as needed for site investigations.

• Proficient in SAP and use of Microsoft programs (Excel, PowerPoint) for data analysis and reporting.

• Six Sigma Green Belt or higher is strongly desired.

• Experience with cGMP or an FDA regulated business a plus.

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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 (http://www.dupont.com/global-links/accessibility.html) .