Anthony Liles

Details

Skills

5S, Access, Agile Project Management, Analysis, CAPA, Certified Lead Auditor, Classroom, Clean Rooms, Computer System Validation, Continuous Improvement, Critical Thinking, Customer Service, Data Analysis, Document Imaging, Employee Training, FDA 21 CFR Part 820, GDP, GMP, Good Clinical Practice (GCP), Integration, Kaizen, Leadership, Lean Manufacturing, LiveLink Doc Control, Lotus Notes, Management, Manufacturing, Manufacturing Directions, Microsoft Excel, Microsoft Word, PowerPoint, Process Improvement, QSR, Quality Assurance, Quality Auditing, Quality Control, Quality Improvement, Quality Management, Quality System, QuickBooks, Regulatory Compliance, Risk Assessment, Root Cause Analysis, SAP, Scanners, SharePoint, SOP, Time Management, Training, Verification and Validation

About

• 14 years’ experience adept assessing total quality management, computerized systems validation, manufacturing processes and making recommendations for production continuous improvement / 4-5 years of Medical Device, Pharma and IVD experience

• Certified Quality Auditor: ISO9001:2015, ISO45001:2018 and ISO14001:2018 (Lead Auditor) and ISO13485:2016 (Internal Auditor)

• Advanced familiarity with and the ability to stay current in general industry standards US FDA QSR 21CFR 820 and cGMP while incorporating generally accepted process improvement techniques (Agile, Lean Six Sigma, Kaizen, 5S)

• Implemented and fostered a QMS culture to obtain ISO 9001:2008, ISO 9001:2015 transition, CCC S&E, and Nemko certificates for 7 consecutive years without any operational non-conformances.

• Successfully defined and implemented ISO 13485 Medical Device QMS registrations for two contract manufacturers resulting in ~$14M in new business revenues.

• Successfully implemented process improvement activities: data analytics, process mapping and defining process ownership to drive an average 30% increase in production month over month and an 18% improvement in accuracy from a Quality Control Rate of 75% in August 2019 to a rate of 93% in March 2020.

• Provided direct oversight to a manufacturing team of 10 Quality Control Technicians.



HIGHLIGHTS



• Technical Writing and Document Control

• Software and Computerized System Validation

• Customer Quality Assurance Surveillance Audits

• Supplier Quality Management

• Equipment Calibrations, Validation, and Operation

• Quality and Process Improvement Projects

• Lean Manufacturing Methodology

• Internal Self-Inspection Audits

• Quality Tools: PDCA, Risk Mitigation, FMEA, Process Mapping, Fish Bone Diagram

• Employee Training Facilitation

• ERP System utilization: SAP R/3, Oracle, MS Dynamics AX