Randy Domingo

FAQ About Randy Domingo

• What is Randy Domingo's address?

  Randy Domingo is located at
  Salt Lake City Metropolitan Area, Salt Lake City Metropolitan Area, United States

• What is Randy Domingo's job title?

  Randy Domingo is a
  My background includes multi-industry Quality and Regulatory experience in Medical Devices (Class II & Class III, SaMD), Pharma, Cell Therapy, Combination Products, and Digital Health. Highly committed to the quality function with extensive experience planning and executing all elements, including not limited to regulatory submissions, total product/system lifecycles, validations, change management, audits & inspections, remediations, CAPAs, GCPs, and GMPs. A servant leader with a dedication of growing globally dispersed, cross-functional team members through training, coaching, and mentorship. Analytical with outstanding foresight, able to draw from past experiences to anticipate areas of risk and implement proper mitigation channels. Outstanding interpersonal and social skills, able to communicate effectively across an organization. When I am not at work, I love to spend time with my family exploring the outdoors, playing the saxophone, road biking, jiu-jitsu, and fly fishing. I'm passionate about health and fitness. I coach Little League Baseball and Youth Soccer. Certifications: • Certified Lean Manufacturing & Six Sigma Black Belt • RAPS Regulatory Affairs Certificate: Medical Devices & Pharmaceuticals (Combination Products) • ISO 13485:2016 QMS and MDSAP Lead Auditor • CRA: Clinical Research Auditor Certified • American College of Sports Medicine Certified Health Professional CORE SKILL AREAS: • Strategic Planning & Execution • Quality Systems Deployment • Change Management Planning & Communications • Regulatory Submissions, Inspections & Readiness • Regulatory Submissions Support: Pre-IND, IND, BLA and 510K and PMA • Continuous Improvement & Predictability • Agile DevOps and Lean Manufacturing • Digital Health/ AI / Machine Learning • Strong financial and business acumen • Performance Metrics and KPIs • Total Product/System Life Cycle Mgmt. • Legacy transfers and remediation efforts • Project Management • SaMD, Paas, SaaS, IoT • GAMP5/CSA Validations & Qualifications • IQ/OQ/PQ and PPQ • Quality By Design/Design Controls • GMP Facility Master Validation Plans • Risk and Complaints Management • Root Cause Analysis and CAPA • ISO 27001, HIPAA, HITRUST, GDPR Compliance • 21 CFR Part 4, 11, 58, 210/211, 820, 1271 • ISO 9001, 13485/MDSAP Auditor • GLPs, GCPs, cGMPs • IEC 62304 Health Catalyst

• What industry does Randy Domingo currently work in?

  Randy Domingo currently works in the
  Health Catalyst

• What is Randy Domingo's area of expertise?

  Randy Domingo specializes in
  My background includes multi-industry Quality and Regulatory experience in Medical Devices (Class II & Class III, SaMD), Pharma, Cell Therapy, Combination Products, and Digital Health. Highly committed to the quality function with extensive experience planning and executing all elements, including not limited to regulatory submissions, total product/system lifecycles, validations, change management, audits & inspections, remediations, CAPAs, GCPs, and GMPs. A servant leader with a dedication of growing globally dispersed, cross-functional team members through training, coaching, and mentorship. Analytical with outstanding foresight, able to draw from past experiences to anticipate areas of risk and implement proper mitigation channels. Outstanding interpersonal and social skills, able to communicate effectively across an organization. When I am not at work, I love to spend time with my family exploring the outdoors, playing the saxophone, road biking, jiu-jitsu, and fly fishing. I'm passionate about health and fitness. I coach Little League Baseball and Youth Soccer. Certifications: • Certified Lean Manufacturing & Six Sigma Black Belt • RAPS Regulatory Affairs Certificate: Medical Devices & Pharmaceuticals (Combination Products) • ISO 13485:2016 QMS and MDSAP Lead Auditor • CRA: Clinical Research Auditor Certified • American College of Sports Medicine Certified Health Professional CORE SKILL AREAS: • Strategic Planning & Execution • Quality Systems Deployment • Change Management Planning & Communications • Regulatory Submissions, Inspections & Readiness • Regulatory Submissions Support: Pre-IND, IND, BLA and 510K and PMA • Continuous Improvement & Predictability • Agile DevOps and Lean Manufacturing • Digital Health/ AI / Machine Learning • Strong financial and business acumen • Performance Metrics and KPIs • Total Product/System Life Cycle Mgmt. • Legacy transfers and remediation efforts • Project Management • SaMD, Paas, SaaS, IoT • GAMP5/CSA Validations & Qualifications • IQ/OQ/PQ and PPQ • Quality By Design/Design Controls • GMP Facility Master Validation Plans • Risk and Complaints Management • Root Cause Analysis and CAPA • ISO 27001, HIPAA, HITRUST, GDPR Compliance • 21 CFR Part 4, 11, 58, 210/211, 820, 1271 • ISO 9001, 13485/MDSAP Auditor • GLPs, GCPs, cGMPs • IEC 62304

• Which languages does Randy Domingo speak? 

  Randy Domingo speaks the following languages:
  No languages available.

• Which industries has Randy Domingo previously worked in?   

  Randy Domingo has prior experience in the following industries:
  Health Catalyst , Renalytixai , Moog , Discgenics , Rb , Edwards Lifesciences , Quest Diagnostics , Stand Up 8 Fitness , Novartis , State Water Resources Control Board California

• What is Randy Domingo’s work experience?  

  Randy Domingo has the following professional experience:
  Health Catalyst , Renalytixai , Moog , Discgenics , Rb , Edwards Lifesciences , Quest Diagnostics , Stand Up 8 Fitness , Novartis , State Water Resources Control Board California .

• How can I find Randy Domingo on LinkedIn?  

  You can view Randy Domingo’s
  LinkedIn profile at LinkedIn URL.

• What are Randy Domingo’s work email addresses?  

  Randy Domingo’s work email addresses are
  [email protected] .

• What company does Randy Domingo work for?  

  Randy Domingo works at
  Health Catalyst