Senior Quality Engineer

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

• Bachelor's degree in Engineering
• Minimum 5 years engineering experience in a regulated industry, preferably in a medical manufacturing environment; 8 years preferred
• Experience in communication and working with a wide variety of associates
• PMP preferred
• Experience working independently and directing others towards a common goal
• Proficient in quality tools including but not limited to: Data/Statistical Analysis, Root Cause Analysis, etc. (preferred)
• Proficient in Microsoft Office and in desktop and mobile technology
  
  

Physical Requirements

• Works under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Occasionally required to lift up to 50 lbs. from floor to waist to move tables, chairs for appropriate room set up
• Occasionally required to stand; walk and stoop, kneel or crouch, communicate