Robert Kruth
Head of Quality & Compliance, Digital Products at Johnson & Johnson MedTech
- Role
- Head of Quality & Compliance, Digital Products at Johnson & Johnson MedTech
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Robert Kruth
Experienced Technical and People leader within MedTech industry. Servant leader helping to build teams that support a diverse and future-focused portfolio. Passionate about leading with a coaching-oriented mindset targeted towards advancing careers. Demonstrated history in leading the construction/update of quality systems and application of Design Controls to new and emerging technologies (Software as a Medical Device, 3D Printing, Robotics, Artificial Intelligence / Machine Learning, and Cloud - IaaS, PaaS, SaaS). Strong background in regulatory compliance and quality system audit across multiple healthcare and technology focused areas.
Experience
Head of Quality & Compliance, Digital Products
Aug 2025 — Present · Cincinnati, OH, US
Education
Penn State University
B.S., Bioengineering with conc. in Materials Science and Engineering
2005 — 2009
Skills
- Failure Mode and Effects Analysis (Fmea)
- Process Improvement
- Minitab
- Fda
- 21 Cfr Part 11
- Fmea
- Technical Writing
- Software Quality Assurance
- Validation
- Software Validation
- Product Support
- Computer System Validation
- Quality System
- Quality Systems
- V&V
- Group Presentations
- Articulate Presenter
- Six Sigma
- Biomedical Engineering
- Iec 62304
- Business Continuity
- Product Innovation
- Process Excellence
- Access Database
- Global Collaboration
- Gmp
- R&D
- Dmaic
- Pro Engineer
- Sourcing & Procurement
- Process Engineering
- Research and Development (R&D)
- Medical Devices
- Mechanical Testing
- Product Development
- Testing
- Technical Presentations
- Spc
- Design Control
- Cross-Functional Team Leadership
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