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Healthcare Contract Manufacturing Quality Engineer
The Contract Manufacturing Quality Engineer is responsible to maintain the assigned business units' quality management system in accordance to 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). This quality engineer role will specifically support the contract manufacturing and MPA Liveo product lines for the healthcare business along with special projects. Location for this role is flexible. The Quality Engineer will report to the Healthcare Business Quality Manager.
Responsibilities:
Responsible for the unit's quality management systems, ensuring alignment with overall 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. This role will also develop and maintain the program to qualify contract manufacturer and run the business activities for contract manufacturing.
SME and lead for the quality aspect of contract manufacturing for the healthcare business. This lead effort includes developing policy or procedures on qualifying and maintaining contract manufacturing resources.
Conduct 1st party and coordinate 2nd and 3rd party quality audits such as ISO, contract manufacturer, supplier, 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 take action 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.
Serve as a Subject Matter Expert (SME) resource for quality training, as needed, for new and existing contract manufacturers. Serve as the SME and site resource for assuring compliance to cGMP standards.
Qualifications:
5 years' experience in a chemical manufacturing environment with processes certified to ISO9001, GMP, NSF, etc.
Bachelor's degree in Engineering, Chemistry or related sciences.
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, carrying out 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 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.
Ability to travel up to 20%
Preferred Skills:
Previous experience with working and qualifying contract manufacturing providers beneficial.
ISO 9001:2015 Lead Auditor Certification is required but may be obtained on the job.
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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On May 22, 2024, we announced a plan to separate our Electronics and Water businesses in a tax-free manner to its shareholders. On January 15, 2025, we announced that we are targeting November 1, 2025, for the completion of the intended separation of the Electronics business (the "Intended Electronics Separation")*. We also announced that we would retain the Water business. We are committed to ensuring a smooth and successful separation process for the Future Electronics business. We look forward to welcoming new talent interested in contributing to the continued success and growth of our evolving organization.
(1)The separation transactions are subject to satisfaction of customary conditions, including final approval by DuPont's Board of Directors, receipt of tax opinion from counsel, the filing and effectiveness of Form 10 registration statements with the U.S. Securities and Exchange Commission, applicable regulatory approvals, and satisfactory completion of financing.? For further discussion of risks, uncertainties and assumptions that could impact the achievement, expected timing and intended benefits of the separation transactions, see DuPont's announcement (http://www.dupont.com/news/dupont-announces-plan-to-separate-into-three-independent-publicly-traded-companies.html) .
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