Quality Engineer II

DuPont•Hemlock, MI

About The Position

At DuPont, our purpose is to empower the world with essential innovations to thrive. We work on things that matter. Whether it’s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric vehicles, or protecting workers around the world. Discover the many reasons the world’s most talented people are choosing to work at DuPont. Why Join Us | DuPont Careers Quality Engineer II The 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.

Requirements

Bachelor’s degree in engineering, chemistry, or related sciences.
5+ years experience in a quality related role in a chemical manufacturing environment with processes certified to ISO 9001, ISO 13485, GMP, NSF, etc.
Ability to understand the quality standards relevant to the industry requirements (e.g., ISO 9001:2015, ISO 13485:2016, 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.

Nice To Haves

Six Sigma Green Belt or higher is strongly desired.
Experience with cGMP or an FDA regulated business a plus.

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.