Quality Engineer 2

 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. 

• 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 standardswhile 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

• 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