Senior Quality Improvement Engineer

Requisition ID: 32180

At Terumo Blood and Cell Technologies, our 7,000+ global associates take pride in their work, understanding that our contributions significantly impact the lives of patients worldwide. For Terumo, for Everyone, Everywhere.

We specialize in the creation of medical devices and related products utilized in the collection, separation, manufacturing, and processing of various blood and cell components. Our innovative technologies and service offerings affect a patient's life every second of every day, and we are dedicated to expanding the number of patients we serve. Advancing healthcare with heart.

With some of the brightest minds in the industry, an unmatched global presence, comprehensive benefits, and a unique culture, Terumo Blood and Cell Technologies is an excellent place to work, develop, and be part of a team committed to making a difference. Join us and help shape our future together.

The Senior Quality Improvement Engineer collaborates with Operational Excellence and cross-functional business partners to evaluate, enhance, and optimize existing quality management system (QMS) processes, ensuring the effective execution of key strategic business initiatives. Acting as the Quality Leader, this role drives continuous improvement initiatives across global sites, delivering sustainable enhancements in product quality, management systems, and services by participating in or leading improvement projects utilizing continuous improvement methodologies. This position also involves creating and delivering relevant LEAN/CI education to foster and maintain a culture of continuous improvement. Furthermore, it supports digital technology and Laboratory Center of Excellence transformation and remediation efforts. Key responsibilities include:

• Reducing CPM.
• Promoting operational excellence across manufacturing facilities by collaborating with Operations.
• Educating non-factory associates on the principles of continuous improvement.

ESSENTIAL DUTIES

• Employs PDCA (Plan-Do-Check-Act) and DMAIC (Define-Measure-Analyze-Improve-Control) methodologies to actively engage in continuous improvement projects that influence product quality and services, aligning quality management system processes with current business needs for the successful execution of strategic initiatives, while developing new processes that significantly impact multiple disciplines.
• Utilizes the E3 concept (Engage, Enable, Empower) within project activities to ensure sustainability with the affected workforce, supervisors, and leaders.
• Provides leadership and guidance to cross-functional managers to achieve site-specific enhancements using Lean and continuous improvement methodologies and tools.
• Supports digital/technology transformation efforts by participating in activities such as value stream and process mapping to optimize new and modified processes and technologies.
• Identifies LEAN/Continuous Improvement needs alongside cross-functional business partners, helping to prioritize and develop implementation plans.
• Leads, coaches, and oversees the Quality Idea Generation Program, assessing system effectiveness to identify unplanned training needs and ensuring personnel engagement. Gathers and analyzes data for monthly reporting on metrics, performance, and progress of ongoing projects.
• Conducts audits and assessments to evaluate implemented improvements and ensure consistency across global sites.
• Participates in digital/technology transformation efforts and Laboratory Center of Excellence implementation by engaging in activities such as value stream and process mapping to enhance new and modified processes and technologies.
• Serves as a consultant on a wide range of complex technical and industry issues for engineering staff and management.
• Addresses complex issues requiring in-depth analysis of variable factors, exercising judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
• Stays informed on recent technical advancements within the industry and applies this knowledge to products and processes.
• Mentors junior engineers.
• Collaborates and ensures alignment with key leaders and stakeholders across functions and within Quality.
• Proactively identifies problems, generates innovative alternatives, and implements creative solutions for complex challenges requiring regular ingenuity.
• Handles significant and unique issues where analysis necessitates evaluation of intangibles, exercising independent judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
• Actively engages, inspires, and drives the effectiveness of teams that integrate multiple functions/disciplines with broad business impact.
• Understands the implications of process changes in one area on other areas and manages the impact of such changes.
• Identifies risks and effectively approaches and completes multiple tasks/projects, avoiding major delays in schedules and product introductions.
• May provide work direction to technicians and junior engineers.
• May collaborate with manufacturing and other functional groups on compliance issues.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor's degree in Business Management, Engineering, or a related field.

Experience

• A minimum of 5 years in business operations and/or plant manufacturing or engineering experience, including 2 years of demonstrated success in process improvement programs.
• Two years of GMP manufacturing experience required. Familiarity with FDA regulatory and ISO requirements and trends affecting medical devices and drug combination products is preferred.
• Black Belt LEAN/Six Sigma certification training or equivalent preferred, or must be completed within the first year.
• Strong professional communication skills and proven leadership capabilities.
• Project management experience and certification preferred.
• Experience in developing and assessing automated and manual assembly manufacturing processes.
• Proficiency in Microsoft Teams, Excel, PowerPoint, Minitab (required), and Power BI (preferred).

Skills

• Demonstrated ability to interact productively and effectively influence peers, external colleagues, and senior management.
• Skilled in motivating teams and stakeholders across diverse sites and cultures.
• Experience in assessing, implementing, and training on engineering best practices.
• Knowledge of FDA regulatory and ISO requirements and trends affecting medical devices and drug combination products.
• Strong coaching and communication skills.
• Ability to identify opportunities where minor changes can lead to transformational improvements by teaching and coaching on Lean/Six Sigma principles.
• Exceptional leadership abilities.

Travel

Domestic and international travel may be required based on business needs.

PHYSICAL REQUIREMENTS

• General Labor Environment requirements include the use of personal protective equipment, reading, speaking, hearing, traversing, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds using carts or mechanized equipment.
• Typical Office Environment requirements include reading, speaking, hearing, close vision, traversing, bending, sitting, and occasional lifting up to 20 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

Target Pay Range: $107,000.00 to $133,000.00, salary determined by education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.

Target Bonus on Base: 7.0%

At Terumo Blood and Cell Technologies, we offer competitive total reward offerings that include compensation, benefits, recognition, and a variety of well-being, work-life, and recognition programs designed to unlock potential for you and your family. Our extensive benefits offerings include multiple group medical, dental, and vision plans, a robust wellness program, life insurance, and disability coverage, as well as various voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance, and more. To assist with retirement savings, we provide a 401(k) plan with a matching contribution, and for work-life balance, we have vacation and sick time programs for associates. For us, it is about safeguarding the personal welfare of our associates and their families, helping to achieve personal goals, and offering those extra touches for convenience, security, and overall peace of mind.

• Terumo Blood and Cell Technologies is part of the Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies achieved $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore, and Tokyo.
• We manufacture devices, disposable sets, and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S., and Vietnam. Our global presence enables us to serve customers in over 130 countries.
• Our core values guide our direction, actions, and commitment to our corporate mission of contributing to society through healthcare:
  • Respect - Appreciative of others
  • Integrity - Guided by our mission
  • Care - Empathetic to patients
  • Quality - Committed to excellence
  • Creativity - Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination based on race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status, or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy, and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace, performing pre-employment substance abuse testing and detailed background verification.