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DELIVERING HIGH QUALITY COMPLIANCE & PROCESS SOLUTIONS |
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Our process excellence, life sciences, and health system improvement expertise
has matured as a result of consultants in-depth talents, hands-on quality/compliance experience, and driving solutions for our
Medical Devices, Pharmaceutical, Diagnostic, Biotechnology, Health Systems, and Process Reengineering Excellence clients.
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Our life science expertise in medical device, biotechnology, diagnostics, biologics, and
pharmaceuticals are built upon extensive experience from leading and supporting multiple global engagements. Our expertise are in areas
such as quality management system, regulatory design, remediation, compliance, product/process validations,
design controls, auditing, QSR, ISO, EU MDR, EU IVDR, and product safety.
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Our process excellence practices developed from expertise in implementing Lean Manufacturing, Six Sigma, Kaizen,
conducting process mapping and team facilitation events driving continuous improvement strategies for operation effectiveness, cost efficiency,
waste reduction. Providing program and project management strategic and tactical support.
Leading business transformation initiatives driving very powerful and sustainable change across manufacturing,
transactional, and life sciences industries has been a staple of our success.
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Our health systems solutions have driven improvements in regional and national hospitals
in driving down patient early readmissions rates, improving corrective action analysis and implementation effectiveness, increasing
joint commission inspection compliance, and improving reimbursement percentage through performance criteria and score enhancement programs.
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Designing, developing, and delivering standardized and customized training classes
and enterprise-wide programs in areas such as ISO 13485, 9001, MDSAP, EU MDR, EU IVDR, Lean Manufacturing, Six Sigma, CMMI, DOE, TRIZ, design innovations and controls, risk management,
regulatory compliance, design and reliability engineering techniques has aided our clients in internal skills development to increase the
performance and effectiveness of their internal processes and operational systems.
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Sr. Program Leader - Regional Health System |
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"Highly talented in performance improvement and is a high energy contributors to teams working on
quality initiatives in healthcare. Brings years of experience in healthcare/technology
and combined with training in Lean Six Sigma provides a unique ability to facilitate efficient and
effective work practices, i.e., drives to get the job done."
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Project Director - National Health Systems |
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"Steve Wallace, the principal consultant has been an inspiring individual to work along side.
You will find him to be experienced, well educated, highly motivated, and one of the hardest working people I've seen in a long time.
He has an amazing ability to understand the strategic picture, and can break down, and dig into the smallest of details.
As an added bonus he is a strong mentor and is fun to work with and leads by example.
I can recommend Steve and his associates without reservation. I look forward to the next opportunity to work for or with Steve Wallace."
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Program Director - Global Medical Device Company |
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"I and my development team worked with Steve in utilization and application of Design,
Reliability, and Manufacturability (DRM) practices in a feasibility analysis of a new product concept for spinal procedures.
I have been impressed with his knowledge of DRM practices and his capabilities in assisting our team in
putting these practices into play in our project. He is extremely knowledgeable, dedicated, and maintains the highest degree of
engagement in working with myself and the team. I would recommend Steve as a colleague and DRM practioner/trainer
and look forward to more interactions with him in the future."
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Consulting Services Owner - Life Sciences |
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"Steven - Hard Working, Integrity and Knowledge.
Not a day went by when I did not learn something new from Steven. He is a vast and dense knowledge
base from Six Sigma to Design and Development. Steven is 100% dedicated to his current task at hand and will
stop at nothing to deliver results. He treats his clients and projects with the
utmost integrity. His hard work and dedication make him a premium asset."
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