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Shafeeq Ahmed

Dynamic and forward-thinking leader with a proven track record in driving innovation & managing complex projects, and improvement... | Seattle, Seattle, United States

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Shafeeq Ahmed’s Location Seattle, Seattle, United States

Shafeeq Ahmed’s Expertise Dynamic and forward-thinking leader with a proven track record in driving innovation & managing complex projects, and improvement initiatives across diverse sectors. Proven expertise in Quality, Regulatory, Quality Management, AI and Continuous Improvement, and cultivating a culture of compliance, growth, and sustainability. Accomplished in strategic planning, training & education, change & performance management, auditing & corrective action, KPI & metrics, and ensuring unwavering commitment to quality & compliance standards. Recognized for establishing robust customer service philosophies and fostering enduring relationships across interdisciplinary teams. REGULATORY EXPERIENCE ● Regulations - ISO/IEC (9001 / 13485 / 14971 / 61000 / 61010 / 60825 / 61326 / 62304 / 62366 / 60601 ), CFR Part 11, 210, 211, 312, 803, 804, 820 QSR’s, BSI, ERES, IVDD/IVDR, NMPA, Canadian CMDCAS, SOX, PMDA, MHLW, MHRA, EU MDR, MDD directives, TGA, PIC/S Annex 11, Ph. Eur., SOC & SSAE 16 std., HIPAA, GDPR, ICH, USP, cGxP, GVP, CE mark & AI / Machine Learning ● FDA Audits & Inspection, For-Cause, MDSAP, Notified Body, TUV, Internal & External Audits, IND, PAI, BLA, NDA, SCAR, Change Control, CAPA, NCR, 510(k), Class I II III Medical Devices, PMA SKILLS ● Technical Skills - Quality Management Systems, CSV, CSA, Post-Market Surveillance, KPIs, Risk Management, Reliability, Safety & Compliance, Apostille process, Parenteral Process, FMEA, MSA, QbD, CtQ ● Leadership & Management - Strategic Direction Setting, Talent Development, Cross-Functional Collaboration, Change Management, Performance Improvement Initiatives ● Financial Oversight & Project Management - KPI & Metrics Establishment/Monitoring, Efficiency Improvement, Compliance Assurance, Root Cause Analysis ● Collaboration & Stakeholder Engagement - External Vendor Collaboration, Competitor and Researcher Communication, Enterprise Quality Practices, Continuous Improvement, Problem-Solving ● Innovation & Continuous Improvement - Process Optimization, Metrics Monitoring and Reporting, Customer Feedback Analysis, Standardization and Visual Controls (5S), Training Program Development, Innovation, Experimentation, and Continuous Improvement ● Software - Jira, Jama, LabVantage, Kneat, Oracle Agile, SAP, Confluence, MasterControl, EtQ, SharePoint, TFS, HP Quality Center, SQL, VMware, Project, Visio, Word, Excel, PowerPoint ● Platforms/Processes - Veeva, Azure DevOps, AWS; Clinical Systems: IRT, eCOA, CTMS; Cloud Computing: SaaS, PaaS & IaaS; Agile: Scrum, Kanban, CI, PB ● Healthcare Standards - Dicom, HL7, Mirth, FHIR, IHE, etc.

Shafeeq Ahmed’s Current Industry Jam Labs

Shafeeq Ahmed’s Prior Industry
Fujifilm Medical Systems Usa | Medicago | Hillrom | Siemens Healthineers | Jam Labs

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Work Experience

Jam Labs

Quality Consultant

Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Siemens Healthineers

Senior Manager

Fri Oct 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Hillrom

Senior Manager

Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Oct 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Medicago

Validation Architect

Sun Oct 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Fujifilm Medical Systems Usa

Quality Engineering Leader

Sat May 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Oct 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

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Shafeeq Ahmed Email Addresses

sh****@si****.com Work Email

sh****@si****.com Personal Email

FAQ About Shafeeq Ahmed

Shafeeq Ahmed is located at
Seattle, Seattle, United States

Shafeeq Ahmed is a
Dynamic and forward-thinking leader with a proven track record in driving innovation & managing complex projects, and improvement initiatives across diverse sectors. Proven expertise in Quality, Regulatory, Quality Management, AI and Continuous Improvement, and cultivating a culture of compliance, growth, and sustainability. Accomplished in strategic planning, training & education, change & performance management, auditing & corrective action, KPI & metrics, and ensuring unwavering commitment to quality & compliance standards. Recognized for establishing robust customer service philosophies and fostering enduring relationships across interdisciplinary teams. REGULATORY EXPERIENCE ● Regulations - ISO/IEC (9001 / 13485 / 14971 / 61000 / 61010 / 60825 / 61326 / 62304 / 62366 / 60601 ), CFR Part 11, 210, 211, 312, 803, 804, 820 QSR’s, BSI, ERES, IVDD/IVDR, NMPA, Canadian CMDCAS, SOX, PMDA, MHLW, MHRA, EU MDR, MDD directives, TGA, PIC/S Annex 11, Ph. Eur., SOC & SSAE 16 std., HIPAA, GDPR, ICH, USP, cGxP, GVP, CE mark & AI / Machine Learning ● FDA Audits & Inspection, For-Cause, MDSAP, Notified Body, TUV, Internal & External Audits, IND, PAI, BLA, NDA, SCAR, Change Control, CAPA, NCR, 510(k), Class I II III Medical Devices, PMA SKILLS ● Technical Skills - Quality Management Systems, CSV, CSA, Post-Market Surveillance, KPIs, Risk Management, Reliability, Safety & Compliance, Apostille process, Parenteral Process, FMEA, MSA, QbD, CtQ ● Leadership & Management - Strategic Direction Setting, Talent Development, Cross-Functional Collaboration, Change Management, Performance Improvement Initiatives ● Financial Oversight & Project Management - KPI & Metrics Establishment/Monitoring, Efficiency Improvement, Compliance Assurance, Root Cause Analysis ● Collaboration & Stakeholder Engagement - External Vendor Collaboration, Competitor and Researcher Communication, Enterprise Quality Practices, Continuous Improvement, Problem-Solving ● Innovation & Continuous Improvement - Process Optimization, Metrics Monitoring and Reporting, Customer Feedback Analysis, Standardization and Visual Controls (5S), Training Program Development, Innovation, Experimentation, and Continuous Improvement ● Software - Jira, Jama, LabVantage, Kneat, Oracle Agile, SAP, Confluence, MasterControl, EtQ, SharePoint, TFS, HP Quality Center, SQL, VMware, Project, Visio, Word, Excel, PowerPoint ● Platforms/Processes - Veeva, Azure DevOps, AWS; Clinical Systems: IRT, eCOA, CTMS; Cloud Computing: SaaS, PaaS & IaaS; Agile: Scrum, Kanban, CI, PB ● Healthcare Standards - Dicom, HL7, Mirth, FHIR, IHE, etc. Jam Labs

Shafeeq Ahmed currently works in the
Jam Labs

Shafeeq Ahmed specializes in
Dynamic and forward-thinking leader with a proven track record in driving innovation & managing complex projects, and improvement initiatives across diverse sectors. Proven expertise in Quality, Regulatory, Quality Management, AI and Continuous Improvement, and cultivating a culture of compliance, growth, and sustainability. Accomplished in strategic planning, training & education, change & performance management, auditing & corrective action, KPI & metrics, and ensuring unwavering commitment to quality & compliance standards. Recognized for establishing robust customer service philosophies and fostering enduring relationships across interdisciplinary teams. REGULATORY EXPERIENCE ● Regulations - ISO/IEC (9001 / 13485 / 14971 / 61000 / 61010 / 60825 / 61326 / 62304 / 62366 / 60601 ), CFR Part 11, 210, 211, 312, 803, 804, 820 QSR’s, BSI, ERES, IVDD/IVDR, NMPA, Canadian CMDCAS, SOX, PMDA, MHLW, MHRA, EU MDR, MDD directives, TGA, PIC/S Annex 11, Ph. Eur., SOC & SSAE 16 std., HIPAA, GDPR, ICH, USP, cGxP, GVP, CE mark & AI / Machine Learning ● FDA Audits & Inspection, For-Cause, MDSAP, Notified Body, TUV, Internal & External Audits, IND, PAI, BLA, NDA, SCAR, Change Control, CAPA, NCR, 510(k), Class I II III Medical Devices, PMA SKILLS ● Technical Skills - Quality Management Systems, CSV, CSA, Post-Market Surveillance, KPIs, Risk Management, Reliability, Safety & Compliance, Apostille process, Parenteral Process, FMEA, MSA, QbD, CtQ ● Leadership & Management - Strategic Direction Setting, Talent Development, Cross-Functional Collaboration, Change Management, Performance Improvement Initiatives ● Financial Oversight & Project Management - KPI & Metrics Establishment/Monitoring, Efficiency Improvement, Compliance Assurance, Root Cause Analysis ● Collaboration & Stakeholder Engagement - External Vendor Collaboration, Competitor and Researcher Communication, Enterprise Quality Practices, Continuous Improvement, Problem-Solving ● Innovation & Continuous Improvement - Process Optimization, Metrics Monitoring and Reporting, Customer Feedback Analysis, Standardization and Visual Controls (5S), Training Program Development, Innovation, Experimentation, and Continuous Improvement ● Software - Jira, Jama, LabVantage, Kneat, Oracle Agile, SAP, Confluence, MasterControl, EtQ, SharePoint, TFS, HP Quality Center, SQL, VMware, Project, Visio, Word, Excel, PowerPoint ● Platforms/Processes - Veeva, Azure DevOps, AWS; Clinical Systems: IRT, eCOA, CTMS; Cloud Computing: SaaS, PaaS & IaaS; Agile: Scrum, Kanban, CI, PB ● Healthcare Standards - Dicom, HL7, Mirth, FHIR, IHE, etc.