Expert Details

Expert in Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt

Expert ID: 735921 Georgia, USA

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Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes, which comply with specific regulatory requirements.

As the Chief Executive Officer of his consulting company, Expert helps medical device companies with a host of FDA regulatory and compliance issues. As a full-service Regulatory, Reliability Consulting, and sales corporation for medical device and product lifecycle, he help companies market novel and advanced medical devices.

• Medical Device Reliability and Test Planning Strategy for Medical Devices
• Quality Assurance and Regulatory Strategy for Medical Devices
• New Product Development Strategy in Lean Six Sigma Healthcare (Continuous improvement program)
• Quality Engineering input to support Manufacturing, Manufacturing Engineering, Operations, and Distribution activities.
• Quality Management System (QMS) implementation
• Develop, establish, and maintain quality engineering methodologies, systems, and practices
• Reduce and control Manufacturing process defects (scrap, nonconforming material, customer complaints) leading or participating in efforts and cross-functional teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• Medical Device Reporting (MDR)
• Internal quality management system (QMS) audits as a Lead Auditor
• FDA New Product Registration, Application submissions
• ISO 9001 Quality system Registration
• ISO 13485 Medical device Quality system Registration
• ISO 14971 Medical Device Risk Management Strategy

Expert in Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems Audits, Reliability Engineering, Lean Six Sigma, Certified Six Sigma Master Black Belt. US FDA Agent - Establishment Registration, FDA 510k Submission, and FDA 483 Observation/warning letter/Recall actions, Canada and EU Medical Device Registration.

• Profound analytical skills
• Excellent communication skills (verbal and written)
• Experience in balancing priorities for short- and long-term goals
• Ability to organize and prioritize to meet deadlines
• Excellent project management skills
• Ability to coordinate multiple projects and meet deadlines

Expert may consult nationally and internationally, and is also local to the following cities: Atlanta - Florida - Washington - Marietta

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Year Degree Subject Institution
Year: 2020 Degree: Dual PhD/Msc Subject: Engineering Management Institution: Walden University, USA
Year: 2010 Degree: Msc Subject: Quality Engineering - Quality Assurance Concentration Institution: Southern Polytechnic State University, USA
Year: 2004 Degree: Bsc. Subject: Biomedical Engineering Institution: University of Applied Sciences Bremerhaven, Germany

Work History

Years Employer Title Department Responsibilities
Years: 2018 to Present Employer: Undisclosed Title: Chief Executive Officer/ Consultant Department: Responsibilities:
• Regulatory Strategy for Medical Devices
• New Product Development Strategy
• Lean Six Sigma Healthcare (Continuous improvement program)
• Quality Management System (QMS) implementation
• Develop, establish, and maintain quality assurance methodologies.
• CE Certification - Medical Devices
• EU Registration - Medical Devices
• EU Technical File / construction /design
• MDD/MDR Reporting
• FDA Medical Device Regulations
• FDA 510k Submission
• FDA 483 Observation/warning letter/Recall actions
• Quality Management System (ISO 9001& ISO 13485) Lead Auditor.
• Regulatory Post Market Surveillance Analysis/Reporting
• FDA New Product Registration, Application submissions
• ISO 9001 Quality system Registration
• ISO 13485 Quality system Registration
• ISO 14971 Medical Device Risk Management Strategy
• Medical Device Single Audit Program Expert (MDSAP)
Years: 2008 to 2019 Employer: Philips Healthcare – Kennesaw, USA Title: Sr. Biomedical / Quality Assurance Engineer Department: Quality Assurance and Regulations Responsibilities: • Lead continuous improvement projects using lean, kaizen, and six sigma concepts.
• Train associates on continuous improvement tools
• Identify and action improvements of current processes with a focus on Lean techniques and simplification.
• Participate in out-of-specification and failure investigations and recommend corrective actions.
• Participate in Medical Device Reporting (MDR) regulation (21 CFR Part 803)
• Compile laboratory test data and perform appropriate analyses.
• Complete documentation needed to support testing procedures including data capturing.
• Evaluate analytical methods and procedures to determine how they might be improved. Identify quality problems, investigate, or report questionable test results.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on the appropriateness of data for release.
• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
• Performs timely, detailed, and independent internal quality management system (QMS), product-focused, and process-focused audits as a Lead Auditor.
• Review responses to audit findings for completeness and effectiveness.
• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends
• Acts as an advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
• Use a data-driven and risk-based approach to scope impact of findings and to identify opportunities for proactive improvements.
Years: 2007 to 2008 Employer: Hewlett Packard – Alpharetta, USA Title: Lead Project Engineer Department: Operations Responsibilities: • Design and develop process workflow in compliance with product requirements.
• Identify risks and issues in business processes and systems.
• Write, schedule, plan, manage and execute process performance qualifications/verifications, and process validations in compliance with product requirements
• Coordinate and collaborate with multiple operational groups including, Research and Development, Quality Assurance, Regulatory Affairs
• Execute on sampling plans and testing of materials and analysis, documentation and reporting of results
• Develop, recommend, and document quality assurance activities on deviations and CAPAs
• Investigate and help to support the resolution of Customer Complaints and non-conformance issues
• Assure ongoing compliance with quality and industry regulatory requirements
• Help to coordinate and support on-site quality / regulatory audits
• Analyze operating data and statistics to identify opportunities, develop action plans, and implement process improvements.
• Monitor and measure the benefits of post-process implementation to ensure product quality, efficiency, and improvement.
• Prepare business process reports for management and customers.

International Experience

Years Country / Region Summary
Years: 1994 to 2005 Country / Region: Germany Summary: International student

Career Accomplishments

Associations / Societies
Orphan Kids Help Foundation
Atlanta Veterans FC
Licenses / Certifications
• Certified Six Sigma Master Black belt (MBB)
• Certified Lean Six Sigma Expert
• Certified ISO 13485 Quality Management Systems specialist including 21 CFR Parts 820 Quality System Regulations
• Certified ISO 14971 Risk Management specialist
• Certified ISO 9001 Lead Auditor
• Certified Japanese Pharmaceutical law expert
• Medical Device Single Audit Program Expert (MDSAP)

Additional Experience

Other Relevant Experience
Computer Skills: SPSS, MINITAB, SAP, CAE, SQL, C++, Excel etc.

Language Skills

Language Proficiency
English Excellent
German Great
French Good
Russian Starter

Fields of Expertise

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