Ron Makar Email & Phone Number
Trainer and Consultant: FDA Medical Device Regulations, ISO 9001:2015, Internal and Lead Auditor @ Axeon Corporation
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Ron Makar Location
- Philadelphia, PA, US
Ron Makar Work
- 2024 -now Trainer and Consultant: FDA Medical Device Regulations, ISO 9001:2015, Internal and Lead Auditor @
- 2015 -now Owner, Principal Consultant @ Innovative Quality Consulting, LLC
- 2021 -now Management Consultant @
- 2015 -now Medical Device Consultant @
- 2011 -2015 Director Quality Management @ Actamax Surgical Materials LLC
- 2007 -2015 Global Quality Manager @
- 2002 -2007 Plant Quality Manager - Newark, DE site @
- 2002 -2007 Plant Quality Assurance Manager @
- 2000 -2002 Quality Assurance Associate @
- 1996 -1999 Quality Assurance Manager @ Dade Behring Inc
- 1994 -1996 Quality Assurance and Compliance Manager @ E.I. DuPont de Nemours & Co., Inc.
- 1993 -1993 Product Quality Management Engineer @ E.I. DuPont de Nemours & Co., Inc.
- 1990 -1992 Production Supervisor @ E.I. DuPont de Nemours & Co., Inc.
- 1989 -1990 Product Quality Assurance Supervisor @ E.I. DuPont de Nemours & Co., Inc.
- 1987 -1989 Process Engineer @ E.I. DuPont de Nemours & Co., Inc.
- 1984 -1987 Systems Support Engineer @ E.I. DuPont de Nemours & Co., Inc.
- 1980 -1984 Product Development Engineer @ E.I. DuPont de Nemours & Co., Inc.
Ron Makar Education
- University of Virginia
Masters in Engineering (Biomedical Engineering)
1978-1980 - University of Bridgeport
Bachelor in Science (WPKN disc jockey (89.5 FM ))
1972-1975 - Norwalk State Technical College
Associate (Electrical Engineering Tech)
1970-1972
Ron Makar Skills
- Problem Solving
- Communication
- Regulatory Compliance
- Global Regulatory Compliance
- Risk Assessment
- Quality Engineering
- Manufacturing Operations
- Medical Device R&D
- FDA GMP
- Supplier Management
- Product Management
- Quality Control
- Supplier Evaluation
- Auditing
- Product Development
- Part 820
- CAPA
- Quality System
- ISO 13485
- Validation
- FDA
- Six Sigma
- Medical Devices
- Lean Manufacturing
- Continuous Improvement
- Quality Assurance
- Quality Auditing
- GMP
- ISO
- Quality Management
- V&V
- Iso 9000
- Design of Experiments
- SPC
- Minitab
- Root Cause Analysis
- Supplier Quality
- FMEA
- Process Simulation
- Change Control
- R&D
- 5S
- Sop
- Leadership
- Research and Development (R&D)
- U.S. Food and Drug Administration (FDA)
- Statistical Process Control (SPC)
- Digital Mammography
- Regulations
- Supervisor
- Omega
- Food
- Data Management
- Sales
- Statistical Process Control Spc
- Registration
- Adhesion
- Assemblies
- Business Analysis
- Preventive Actions
- Interventional
- Hazard Analysis
- Materials
- Engineering
- Inspection
- QC
- Compliance
- Operations
- Medical Device Directive
- Research And Development R&D
- Cycle Time Reduction
- Work Instructions
- Contract Manufacturing
- CMOS
- Risk Management
- Production Supervisor
- Training
- Change Management
- Facilitation
- Manufacturing
- U.S. Food And Drug Administration Fda
- Business Launch
- Barrier
- Parts
- Business Management
- Design
- Project Management
- Vegetarian
- Dsm
- Cfr
- Cost Reduction
- Commercialization
- Development Planning
- Integration
- Product Quality
- Research and Development
- u.s. Food and Drug Administration
- Statistical Process Control
Ron Makar Summary
- Ron Makar, based in Philadelphia, PA, US, is currently a Trainer and Consultant: FDA Medical Device Regulations, ISO 9001:2015, Internal and Lead Auditor at Axeon Corporation. Ron Makar brings experience from previous roles at Innovative Quality Consulting, LLC, Oriel STAT A MATRIX, The Quantic Group Ltd and Actamax Surgical Materials LLC. Ron Makar holds a 1978 - 1980 Masters in Engineering in Biomedical Engineering @ University of Virginia. With a robust skill set that includes Problem Solving, Communication, Regulatory Compliance, Global Regulatory Compliance, Risk Assessment and more. Ron Makar has 1 emails on RocketReach.
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