Michael Kuehne Email & Phone Number

Founder | Principal ComplyFDA.com @ ComplyFDA.com

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Michael Kuehne Location

Belmar, NJ, US

Michael Kuehne Work

2019 -now Founder | Principal ComplyFDA.com @
2016 -now Student Mentor @ Rutgers College of Engineering
2019 -2023 Vice President Quality and Compliance @
2018 -2019 Sr Director Quality @
2018 -2019 Sr Director Quality @
2017 -2018 VP Quality, Compliance and Regulatory Affairs @
2017 -2018 VP Quality, Compliance and Regulatory Affairs @
2013 -2017 Senior Director Quality and Tissue Services @
2013 -2017 Senior Director Quality and Tissue Services @
2010 -2013 Director, Corporate Quality and Regulatory Processes @ C.R. Bard
2010 -2013 Director, Corporate Quality and Regulatory Processes @ C.R. Bard
2007 -2010 Director, Quality Systems Development, R and D and Production Support @ TyRx Pharma, Inc
2007 -2010 Director, Quality Systems Development, R and D and Production Support @ TyRx Pharma, Inc
2001 -2007 Managing Principal @ ACSYS, Inc.
2001 -2007 Managing Principal @ ACSYS, Inc.
1994 -2001 Director WW Packaging and Engineering @ Cordis, Johnson & Johnson
1994 -2001 Director WW Packaging and Engineering @ Cordis, Johnson & Johnson

Michael Kuehne Education

Rutgers College of Engineering
BSEE (Electrical and Electronics Engineering)

Michael Kuehne Skills

Medical Devices
Quality Systems
Validation
FDA
R&D
V&V
Cross-functional Team Leadership
GMP
Process Engineering
Quality System
Change Control
ISO 13485
Pharmaceutical Industry
Process Improvement
Design Control
Manufacturing
FMEA
CAPA
Sop
Process Simulation
Root Cause Analysis
Six Sigma
Product Development
ISO
Quality Assurance
21 CFR Part 11
Product Launch
Biotechnology
Technology Transfer
Quality Control
Life Sciences
Laboratory
Continuous Improvement
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
Biopharmaceuticals
Microsoft Power BI
Auditing
Process Operations
Oncology
Corporate Office
Management
DMAIC
DEA
Change Management
Transplant
Guidelines
Facility Expansion
Payback
Gap Analysis
Foundation
Foam
Accountability
Microbiology
Safety
Development Programs
Business Expansion
Responsiveness
Compliance
Life Cycle Management
Process Excellence
Competition
Software
Internal Audit
Vacuum
Organizational Culture
Netherlands
Cross Functional Team Leadership
Credit Scoring
Clean Rooms
Rx
FIX Protocol
Associate Development
Medical Diagnostics
Sourcing
Cabinet
Support Groups
Engineering
Combination Products
Baby Products
Consumer Products
u.s. Food and Drug Administration Fda
Contractual Agreements
Information Management
Product Quality
Environmental Monitoring
Organizational Development
Project
Newsletters
Software Installation
Delivery
Laser Cutting
Miami
Stents
Qualification
Standard Operating Procedure Sop
Technical Teams
Graphs
Project Management
Stage
Training Programs
Risk Assessment
System Monitoring
Science
Supply
Metrics
Testing
Regulatory Risk
Surgery
Data Acquisition
Interfaces
Hygiene
System
Emerging Technologies
Responsibility
Patents
Intelligence
Marketplace
Biologics
Batch Release
Pharmaceutical Manufacturing
Black Belt
Remediation
Fortune 100
Process Transfer
Art
Letters
Supplier Management
Design
Musculoskeletal
Students
Quality Processes
World Class
Packaging
Regulatory Compliance
Hillsborough
Innovative Technologies
Council
Human Resources
Clinical Research
New Process
High Speed
Efficiencies
Green Belt
Fortune 500
Performance Management
Streamline
Driving
Highlighting
Due Diligence
Paperless
Diagnostics
Risk
Strategic Initiatives
Lake Homes
Google Groups
Coatings
Facilities Management
Outsourcing
Indications
Pharmaceutics
Concepts
Recruiting
Regulatory Affairs
Catalyst
Product Requirements
Voice
High Potential
Start Ups
Ortho
Regulations
Tissue
Organizational Structure
Accounting System
Mentoring
Presentations
Guidance
C
Negotiation
Prototype
Electropolishing
Budgets
Microsoft Excel
Suppliers
Strategic Planning
Regenerative Medicine
Software Validation
Process Validation
Consulting
Creams
CIM
Operational Activities
Technical Support
Gaps
Data Management
Policies and Procedures
Oversight
Test Scripts
Consumer
Culture
Stocks
Technology Development
Instant Messaging
Applications
Lead Development
Methodology
Implants
Code
Flexible
Cleaning Validation
Denmark
Medicine
Infrastructure
Piloting
Materials Management
Execution
Process Design
Microsoft Office
Partnerships
Transformational Leadership
Cost Savings
Capital
Dia
R
Publications
External Relationships
Policy
Data Center Infrastructure
Clinical Development
Polymers
Electrical Engineering
Histology
Intense
Reporting
Performance Improvement
Evaluation
Savings
Sales
Informatics
International
Training
Hard Drives
Strategies
Relationship Building
Automation
Control Systems Design
Succession Planning
Organizational Performance
Results Driven Leader
Americas
Strategy
Raritan
Reporting Systems
Franchising
Production Equipment
Research
Operations
Business Rules
Electronics
Management Development
Computer Graphics
Communication
Rate
Third Party
Efficient
American
Qualify
Issue Management
Assessment
Engagement
Inspection
Reports
Technology Implementation
u.s. Food and Drug Administration
Standard Operating Procedure

Michael Kuehne Summary

Michael Kuehne, based in Belmar, NJ, US, is currently a Founder | Principal ComplyFDA.com at ComplyFDA.com. Michael Kuehne brings experience from previous roles at Rutgers College of Engineering, MICRO and bluebird bio. Michael Kuehne holds a BSEE in Electrical and Electronics Engineering @ Rutgers College of Engineering. With a robust skill set that includes Medical Devices, Quality Systems, Validation, FDA, R&D and more. Michael Kuehne has 4 emails and 4 mobile phone numbers on RocketReach.