With over 30 years of international experience, Ed Siurek is a distinguished Quality Professional specializing in compliant, efficient process development. Leveraging his years in the pharmaceutical and medical device industry and his Lean Six Sigma Black Belt, Ed is known for leading organizational change and operational projects that deliver sustainable and measurable results. While formally trained in Lean Six Sigma, Ed excels at selecting the right tools for each situation, utilizing a broad array of proven techniques to achieve organizational goals effectively.
Ed’s extensive background spans environments from startups to global operations teams to working with over 400 consulting engagements with clients of all sizes. In each case, he stives to ensure all relevant project inputs are considered to identify and implement optimal quality solutions.
Working with members across industries, Ed has been instrumental in developing and leading numerous public and private training sessions on various aspects of Quality Management Systems. With his extensive knowledge and personal approach, Ed employs a variety of techniques to ensure that participants find value in his sessions and can immediately apply their learnings to their work.
Global Leadership in Quality
Ed has participated in and led numerous discussions with authorities in the US, Austria, Latvia, Japan, Spain, Mexico, Czech Republic, and Germany. He has facilitated plant openings, inspections, and product introductions, showcasing his expertise in quality management. In his global role, he was responsible for overseeing quality and regulatory goals across four continents and over 55 countries, ensuring consistent implementation while meeting stringent operational margin goals.
Areas of Expertise
• Lean Six Sigma Green / Black Belt
• Continuous Improvement
• Project Management
• Operational Efficiency
• Business Metrics
• US FDA Pharmaceutical and Medical Device Regulations
• Process Validation
• EU Medical Device Regulations
• Lead Auditor
• Problem Solving 
