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Senior Quality Manufacturing Engineering Specialist

2 months ago

Denver, Colorado, United States EPM Scientific Full time

Overview:

The Senior Quality Manufacturing Engineering Specialist partners with Operational Excellence and interdisciplinary teams to assess, enhance, and optimize existing Quality Management System (QMS) protocols, ensuring the effective implementation of pivotal strategic initiatives. As the Quality Authority for the global Business Excellence program, this position drives enduring enhancements in product quality, management systems, and services by spearheading or engaging in continuous improvement projects. The role also encompasses the development and delivery of LEAN/Continuous Improvement (CI) training to cultivate a culture of ongoing enhancement, supporting digital technology initiatives, and supervising Laboratory Center of Excellence transformation and remediation efforts. Furthermore, the Specialist leads and mentors the Business Excellence and Six Sigma Training Programs and Kin-Shitsu Projects.

Key Responsibilities:

  • Minimizing CPM (Cost per Million)
  • Advancing operational excellence across manufacturing sites in collaboration with Operations
  • Instructing non-manufacturing personnel to adopt and execute continuous improvement methodologies

Essential Duties:

  • Engage in continuous improvement initiatives that elevate product quality and services. Align QMS processes with contemporary business requirements for the successful execution of critical business initiatives and develop impactful new processes.
  • Implement 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 enhancements using Lean and continuous improvement tools and methodologies.
  • Lead/support the identification of LEAN/Continuous Improvement needs in collaboration with cross-functional business partners. Assist in prioritizing and developing implementation strategies.
  • Lead, coach, and oversee the Six Sigma Training Program. Evaluate 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 enhancements 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 modified processes and technologies.
  • Serve as a consultant on a broad range of complex technical and industry issues for engineering staff and management.
  • Address complex challenges that necessitate an in-depth evaluation of variable factors. Exercise judgment in selecting methods, techniques, and evaluation criteria for achieving results.
  • Stay informed 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 challenges, 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.