Scott Engelking

About Scott Engelking

I am a goal-oriented Regulatory Affairs and Quality Assurance Professional with international quality systems experience in Medical Device, Pharmaceutical and Combination Products manufacturing management. I am skilled at producing results by providing leadership, direction and consultation for all quality processes ensuring compliance with regulations and requirements. I have extensive knowledge of identifying root causes of issues, and the development and implementation of continuous improvement initiatives resulting in in robust processes and procedures. My focus on continuous improvement with a risk-based analysis enables me to implement cross-functional improvements to identify redundancies, increase efficiency, and reduce costs. • Successfully transitioned to ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP).• Successful compliance record with the FDA, EU ISO Notified Bodies, Health Canada and S. Korea. • Performed successful transition to new ISO 14971:2012 Standard.• Promoted after consistently exceeding goals and objectives.• Awarded for streamlining processes which improved efficiencies and reduced errors by 25%. • Awarded for streamlining approval and start-up processes which improved efficiency by 15%.Training and Professional DevelopmentQuality Management System Internal Auditor ISO 9001:2015 & ISO 13485:2016FDA 21CFR Parts 11, 220, 211, 803, 806, 820 and 822 | EU Medical Device Directive (MDD) and Regulation (MDR)Health Canada Medical Device Regulation and Medical Device Single Audit Program (MDSAP)South Korean Ministry of Food and Drug Safety RegulationsFDA, Foreign Country and External Quality System AuditsISO 13485 and ISO14971Medical Device Design and Development, Design Controls, Technical File CompilationCorrective and Preventive Action (CAPA)\\ Root Cause AnalysisFailure Mode and Effect Analysis (FMEA)Specialties: • U.S and Foreign Country Regulations and Certifications• Quality Management Systems, Operational Excellence and Continuous Improvement• Regulatory Intelligence Management• ISO 9001 and 13485 Auditing, CAPA, Risk Management and Nonconformance Investigations • Root Cause Analysis, and CAPA Effectiveness Verification• Failure Mode Effect A••••••••@gmail.com

Experience

1. Consultant

   Aditi Consulting

   Jul 2024 — Present · Clearwater, FL, US

   Responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints; preparing annual product reviews, tracking and trending, and follow-up of the Change Control and CAPA programs.• Collaborate with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution• Prepare APRs in accordance with site procedures and timelines.• Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.• Assess product complaints and APR trends, provide guidance and collaborate on plans of action to address trends as per site SOPs.• Participates in the internal audit program.

Education

• Indiana State University

  B.S., Physical Education, Sports Studies