Aaron Ogrodnik
Medical Device Quality Assurance and Regulatory Affairs Professional
- Role
- Principal Quality Engineer at Itron, Inc.
- Location
- Pendleton, SC, US
- LinkedIn followers
- 500 followers
About Aaron Ogrodnik
With more than ten years of experience in the medical device industry, I am a Principal Quality Engineer at Olympus. I hold certifications in quality engineering, project management, regulatory affairs, and six sigma, demonstrating my proficiency and commitment to excellence in my field.My core competencies include MDR/IVDR technical file preparation, risk management, and quality management systems, which enable me to collaborate effectively with cross-functional teams and ensure adherence to global regulations. I have successfully delivered multiple projects for clients ranging from start-ups to Fortune 500 companies, achieving high customer satisfaction and quality outcomes. I am passionate about driving compliance, leading teams, and achieving project goals in the dynamic and challenging MedTech environment.
Experience
Principal Quality Engineer
Oct 2025 — Present · West Union, SC, US
Education
Clemson University
Bachelor of Science (BS), Materials Science and Engineering
2010 — 2015
Skills
- Solidworks
- Materials Science
- Chemistry
- Polymer Chemistry
- Scifinder Scholar
- Afm
- Research and Development (R&D)
- Scrap Monitoring
- Nanotechnology
- Biomaterials
- Microsoft Powerpoint
- Scanning Electron Microscopy
- Engineering
- Powder X-Ray Diffraction
- Change Control Review
- Microsoft Word
- Research
- Nonconforming Material Reports
- R&D
- Matlab
- Powerpoint
- Microsoft Excel
- Design of Experiments
- Manufacturing
- Characterization
- Microsoft Office
- Public Speaking
- Chemical Engineering
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