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Compliance 360 Consulting LLC Expertise

Our expertise and personal brand is what gives us a competitive advantage.

 

With 25+ years of Medical Device Industry experience in Global Quality Management System (QMS) and Quality System Regulation (QSR) leading QMS implementation, integration and remediation and hand-on, big picture thinker unique skills set

In depth expertise in Project Management, PostMarket Surveillance and Risk Management, with Product design and development, Systems Integration and Clinical Validation background, as well as natural ability to lead teams and share expertise, we will make your Company success our personal goal. We will work together to ensure that Quality and Compliance is your mind set going forward.

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Whenever you work with Compliance 360 Consulting, you can trust that you’re in great hands

Core Expertise

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  • Medical Device Class I-III and Combination Products Experience 

  • Quality Management and Regulatory Compliance

  • Risk Management Integration, ISO 14971

  • Medical Device Reporting (MDR/MDV) 

  • Implantable | IVD | Medical Imaging 

  • Complaints Management and Remediation

  • Field Corrective Action & Recalls

  • PostMarket Surveillance

  • ISO 13485, ISO 9001

  • EU MDR/IVDR

  • QSR/NPD Activities 

  • Quality Data Review and Trending

  • Risk Acceptability Analysis

  • Program/Project Management

  • Corrective Action/Preventive Actions (CAPA)/NCR Procedures/CRB Management

  • Global Logistics and Distribution

  • SmartSolve, TrackWise, SAP, Salesforce, Tableau, QAD/CEBOS, MS Excel, Minitab 

  • Lean Six Sigma Certified

  • MSCE/MBA – Masters of Computer Engineering/Master of Business Administration (MBA)

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Core Competencies

  • Strong Leadership – Effectively Leading global teams, able to build confidence in others

  • Ability to influence without authority 

  • Managing and measuring work

  • Creative problem solver and change agent who is looking for faster and better ways

  • Effective communication and collaboration skills 

  • Ability to review, analyze, summarize, and interpret data, draw conclusions and make appropriate recommendations and decisions, write reports and give oral presentations.

  • Trending quality data, presenting internally as well as at external conferences

  • Process/Project/Program Management 

  • Continuous Process Improvement – Change champion and/or core team member in multiple process improvement initiative

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