Overview:
The Quality Manufacturing Engineering SME collaborates with Operational Excellence and cross-functional teams to evaluate, refine, and streamline existing Quality Management System (QMS) processes, ensuring the efficient execution of key strategic initiatives. As the Quality Leader for the global Business Excellence program, this role drives sustainable improvements in product quality, management systems, and services by leading or participating in continuous improvement projects. The role also involves creating and delivering LEAN/Continuous Improvement (CI) training to foster a culture of continuous improvement, supporting digital technology initiatives, and overseeing Laboratory Center of Excellence transformation and remediation efforts. Additionally, the SME leads and coaches the Business Excellence and Six Sigma Training Programs and Kin-Shitsu Projects.
Responsibilities:
- Reducing CPM (Cost per Million)
- Promoting operational excellence across factories in partnership with Operations
- Educating non-factory associates to embrace and implement continuous improvement practices
Essential Duties:
- Engage in continuous improvement projects that enhance product quality and services. Align QMS processes with current business needs for the successful execution of key business initiatives and develop impactful new processes.
- Apply the E3 concept (Engage, Enable, Empower) in project activities to ensure sustainability with affected workforce, supervisors, and leaders.
- Provide leadership and guidance to cross-functional managers to achieve site-specific improvements using Lean and continuous improvement tools and methods.
- Lead/support the identification of LEAN/Continuous Improvement needs in collaboration with cross-functional business partners. Assist in prioritizing and developing implementation plans.
- Lead, coach, and provide oversight for the Six Sigma Training Program. Assess system effectiveness, identify unplanned training needs/system gaps, and gather and analyze data for monthly reporting on project metrics, performance, and progress.
- Conduct audits and assessments to evaluate the consistency and effectiveness of implemented improvements across global sites.
- Support digital/technology transformation and Laboratory Center of Excellence initiatives by participating in activities such as value stream and process mapping to optimize new and changed processes and technologies.
- Serve as a consultant on a broad range of complex technical and industry issues for engineering staff and management.
- Tackle complex issues that require an in-depth evaluation of variable factors. Exercise judgment in selecting methods, techniques, and evaluation criteria for achieving results.
- Stay updated on the latest technical advancements in the industry and apply this knowledge to products and processes.
- Contribute to the establishment of business objectives, goals, budgets, and costs as needed.
- Mentor less experienced engineers.
- Collaborate and ensure alignment with key leaders and stakeholders across functions and within Quality.
- Anticipate problems, generate advanced technical alternatives, and implement innovative solutions for complex problems requiring ingenuity and creativity.
- Address significant and unique issues where analysis requires evaluating intangibles. Exercise independent judgment in selecting methods, techniques, and evaluation criteria for achieving results.
- Actively engage, inspire, and enhance the effectiveness of teams that integrate multiple functions/disciplines and have a broad business impact.
- Understand the impact of process changes in one area on other areas and manage these changes effectively.
- Identify risks and manage multiple tasks/projects to avoid major delays in schedules, product introduction, or potential loss of business.
- Provide work direction, which may include supervising technicians and junior engineers.
- Collaborate with manufacturing and other functional groups on issues related to manufacturing and regulatory compliance.
Minimum Qualification Requirements:
Education:
- Bachelor’s degree in Business Management, Engineering, or a related field, or equivalent education and experience sufficient to perform the job’s essential functions.
Experience:
- At least 8 years of experience in business operations, plant manufacturing, or engineering, including 3 years of demonstrated success in process improvement programs.
- At least 2 years of GMP manufacturing experience is required. Knowledge of FDA regulatory and ISO requirements and trends affecting medical devices and drug combination products is preferred.
- Black Belt LEAN/Six Sigma certification is required or must be obtained within the first year.
- Strong communication and proven leadership skills.
- Project management experience and certification are preferred.
- Experience in the development and assessment of 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 influence peers, external colleagues, and senior management.
- Skilled in motivating and influencing teams and stakeholders across different sites and cultures.
- Experience in assessing, implementing, and training 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 for transformational changes through small improvements by teaching and coaching on Lean/Six Sigma principles. Strong leadership abilities.
