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We are seeking a seasoned professional to join our Industrial Solutions business on a full-time, direct basis as our _Quality Manager_ at our facility in Hemlock, MI. We are looking for a highly-motivated _Leader_ to support Quality Improvement initiatives (short-term & long-term) for our Liveo™ Healthcare operations; this involves supporting our customers and production sites.

This person will define strategic direction and manage quality activities for local Healthcare Industries Materials Site [HIMS] operations as well as contract manufacturers (globally); this involves providing direction & objectives to meet customer quality needs and assure compliance to applicable regulations (including U.S. Food & Drug Administration [FDA] guidelines). This person will also drive improvements to the Quality Management System [QMS] to meet healthcare market quality requirements (including Current Good Manufacturing Practice [cGMP] standards). This person will provide leadership while maintaining accountability for all Quality activities within the business unit (including the QMS, customer satisfaction, quality certifications, quality-related aspects of supplier relationships, training, quality audits, and Corrective and Preventive Action [CAPA] initiatives. This person will also work closely with Senior Business Management to drive continuous quality improvement.

PRIMARY DUTIES & RESPONSIBILITIES:

+ Define Quality objectives to meet business long-term goals and customer requirements for the Liveo™ healthcare business; this involves working across the local operations and contract manufacturers.

+ Ensure the quality requirements for relevant quality standards (e.g.: ISO-9001:2015, ISO-13485:2016, etc.) are implemented and maintained in accordance with cGMP (US 21 CFR 820) and FDA regulations.

+ Lead the overall Liveo™ Quality unit, especially with people leadership and mentoring of the Quality Team.

+ Work in a highly-matrixed and geographically-diverse business environment.

+ Develop and deliver cGMP & quality training to all required personnel involved with manufacturing healthcare products.

+ Negotiate and approve Quality Agreements.

+ Interact with clients; this person will ensure customer complaints & inquiries are effectively addressed in a timely manner.

+ Manage quality-related customer communication and assure proper customer change notification workflows are followed.

+ Proactively seek global alignment / interpretation in application of relevant policies & procedures.

+ Work closely with the Commercial and Technical Organization on improvement plans for the business.

+ Establish quality goals for the site and contract partners.

+ Support quality activities for Technical Service & Development [TS&D] as well as New Product Development [NPD] initiatives.

+ Develop Roadmap(s) for Future Harmonized processes in the Quality Organization and cross-functional teams.

+ Foster a safety-first mentality while improving efficiency through the improvement of process flow, elimination of waste, and cost reduction (through leadership, example, and training).

+ Ensure critical suppliers are held to the highest standards and are monitored appropriately through audit programs.

+ Oversee the Computerized Quality System Software Validation to ensure new systems and system changes are managed consistently with regulatory & business requirements.

+ Support cross-functional Quality Management Reviews.

+ Additional duties may be assigned, as needed.

QUALIFICATIONS:

Basic Requirements:

+ Bachelor’s degree.

+ 5+ years of professional experience working in Quality and/or Industrial Operations.

Preferred Qualifications:

+ Completion of a degree in a technical field of study (e.g.: Industrial Engineering, Chemistry, etc.).

+ Relevant credentials (e.g.: ISO Lead Auditor Certification, Six Sigma Green Belt (or higher), etc.).

+ Experience working in a process manufacturing environment, preferably in a regulated industry (e.g.: medical, pharmaceutical, etc.).

+ Broad experience working with various areas of industrial quality: Quality Assurance [QA], Quality Control [QC], Supplier Quality Management, etc.

+ Experience with relevant quality standards & regulations (e.g.: ISO-9001:2015, ISO-13485:2016, cGMP, FDA, etc.) as well as developing necessary controls to achieve / maintain compliance.

+ Demonstrated ability to understand, calculate, establish, and communicate key quality metrics (including complaints, Cost of Poor Quality, complaint frequency, cycle time, corrective actions, and audit results).

+ Demonstrated experience in auditing, carrying out root-cause failure analysis, and identifying & driving closure on critical CAPA initiatives.

+ Advanced experience improving manufacturing process capability, especially with data-driven processes.

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

+ Proven expertise with Operational Excellence [OpEx] / Continuous Improvement; expertise with formal methodologies (e.g.: Lean Manufacturing, Toyota Production System [TPS], Six Sigma, etc.) is a plus!

+ Demonstrated leadership skills as to drive quality improvements; this includes a variety of competencies (e.g.: bias for action, integrity, judgement, solid time management skills, change agent behavior, etc.).

+ Experience working in a managerial / supervisory role, especially with formal staff leadership responsibilities; experience with hiring new staff as well as developing and managing a team is a plus!

+ Experience working in a client-facing role; this person is expected to regularly interact with a variety of clients & customers.

+ Proven ability to maintain accountability to meeting commitments, both with yourself and others.

+ Proficiency with relevant computer programs (e.g.: SAP, MS-Office, etc.); experience with data analysis & reporting, especially with utilizing statistical analysis software, is a plus.

+ Strong analytical and problem-solving abilities.

+ Demonstrated ability to work independently, take initiative, and lead development efforts; this person will be expected to inspire and motivate others while establishing effective processes and controls.

+ Proven ability to display excellent organizational and project management skills.

+ Advanced networking and influencing skills; this person is expected to earn broad-based credibility with internal & external shareholders.

+ Excellent communication skills (written & verbal); this person will be expected to deliver complex messages in a clear manner.

Join our Talent Community (http://careers.dupont.com/us/en/jointalentcommunity) to stay connected with us!

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) ._

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) .

DuPont offers a comprehensive pay and benefits package. To learn more visit the Compensation and Benefits page (http://careers.dupont.com/us/en/compensation-and-benefits) .