Overview As a Quality Engineerfor Project leadership, you'll be the quality representative on strategic Quality Improvement projects and business initiatives that evolve and improve how we work every day. This role offers a unique opportunity to be a highly visible and integral part of projects across the organization and be part of dynamic teams driving positive changes. Including: + Leadership Opportunities: Lead projects that span multiple functional areas and contribute to significant organizational improvements. + Collaborative Environment: Work with diverse teams dedicated to quality and innovation. + Impactful Work: Be part of initiatives that drive positive changes and enhance product quality and safety. + Highly Visible: Work with key leaders and teams across the organization on Break Through Objectives (BTOs) and Business Improvement Priorities (BIPs) + Professional Growth: Access continuous learning and development opportunities to advance your career. This position will not provide sponsorship opportunities. Responsibilities + Benchmark best practices across Cook Medical and beyond to improve the how we meet the needs of our business. + Deliver improved Quality practices to positively impact our people, transform our Quality processes, and improve our products. + Ensure Efficient Compliance: Perform work in accordance with external and internal quality standards while reducing redundancies and non-value added activities . + Collaborate and Communicate: Interface with internal and external groups on quality-related projects , incorporating creative ideas, fostering strong relationships and effective communication. + Represent Cook Inc. on major entity or company-wide initiatives + Work with Global Cook Medical entities to represent global Quality needs and influence enterprise projects + Change Management: Manage dynamic projects and communicate the benefits of change throughout the organization. + Lead Decision Making: Utilize risk-based decision making to resolve issues effectively and efficiently. + Develop tools to determine cost of quality savings on projects. Track, report, and celebrate these benefits. + Champion Quality System Improvement: Drive QMS improvement efforts by facilitating, leading, and collaborating with cross-functional teams + Provide Leadership: Offer leadership in medical device regulations and best practices, guiding teams towards efficiency, compliance , and excellence. + Resolve Conflicts: Manage conflict resolution in technical situations, ensuring collaborative, effective , and timely solutions. + Commit to Growth: Maintain all training requirements for the position while seeking opportunities for continuous development and growth. + Adhere to Standards: Follow the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements. • Must strictly adhere to safety requirements Qualifications • Bachelors degree in Engineering (Biomedical, Industrial, Mechanical) • Minimum of 3 years experience • Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)• Professional certification (e.g. ASQ, Six Sigma, etc.) preferred • PMP preferred• Proficiency in statistical, quality and continuous improvement methods and tools • Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.• Strong organizational skills• Critical thinking and attention to detail required• Excellent verbal communication skills and technical writing Physical Requirements: • Works under general office environmental conditions, including time in manufacturing environment and biohazard lab• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.• Occasional travel may be required Requisition ID2025-16237 Posting Date3 days ago(3/5/2025 4:19 PM) Job Location(s)Bloomington IN United States Job LocationsUS-IN-Bloomington Position TypeFull Time CompanyCook Inc - Bloomington CategoryQuality