Medical Device Quality Management Systems - Strategy and Techniques for Improving Efficiency and Effectiveness

Susanne has 30 years’ experience at leading companies Medtronic, Johnson and Johnson, and GE with a proven track record in quality and compliance. Demonstrated ability to assess quality/compliance gaps, develop and successfully implement innovative strategies and cost-effective risk mitigation plans. Proven skills in developing quality objectives, metrics, and plans to ensure effective management review and oversight leading to improved quality, customer satisfaction, regulatory compliance… Show more Susanne has 30 years’ experience at leading companies Medtronic, Johnson and Johnson, and GE with a proven track record in quality and compliance. Demonstrated ability to assess quality/compliance gaps, develop and successfully implement innovative strategies and cost-effective risk mitigation plans. Proven skills in developing quality objectives, metrics, and plans to ensure effective management review and oversight leading to improved quality, customer satisfaction, regulatory compliance, and business success. Experienced in medical devices, med-tech, diagnostics, biologics, complex systems, and combination products. Expert in Medical Device Regulations. Her book, Medical Device Quality Management Systems - Strategies and Techniques for Improving Efficiency and Effectiveness, was published in October 2018 by Academic Press, an imprint of Elsevier.Qualifications:• ASQ CQA (Certified Quality Auditor)• Certified Master Black Belt in Six Sigma / Lean• RAPS RAC (Regulatory Affairs Certification)• BS in Biomedical Engineering• MBA• Patent for Predictive Indicator Model for Quality ImprovementServices:• Establishment of Quality Systems• Quality Systems Auditing • Due Diligence• Predictive Compliance• Training and Education• FDA and Notified Body Inspection Readiness• Risk Management and Mitigation• Management Review• Quality Improvement• Six Sigma / Lean Solutions and Training• Supplier Management• Validation• CAPA• Failure Investigations and Problem Resolution• 483 / Warning Letter responses and mitigation Show less