Adrian Cole
Senior Director of Quality | Purchasing/Supplier and Post Market Surveillance Controls | Medical Device Industry | Indianapolis Colts Fan
- Role
- Director, Post Market Quality and Surveillance at Merit Medical Systems, Inc.
- Location
- Powell, OH, US
- LinkedIn followers
- 500 followers
About Adrian Cole
Transformational leader and team builder in quality and operations with specialization in External Quality, Production and Process Control and Design Control in the Medical Device, Automotive and Industrial Automation industries. General interests include the deployment of effective strategy in organizational design and team formation to ensure patient safety and greater regulatory compliance.
Experience
Director, Post Market Quality and Surveillance
Jun 2024 — Present · US
Global team leader and process owner for Post Market Surveillance and OEM quality. Proactively identified and implemented remediation plans to address significant process gaps in complaint handling processes including influencing C-level leadership to fund interim and permanent resourcing to prevent disruption to business success from possible regulatory action. Additional activities include authoring multiple regulatory responses, significant productivity improvements in complaint handling and realignment of risk management and post market surveillance documentation teams.
Education
Ball State University
B.S., Manufacturing Engineering Technology
1997 — 2002
North Carolina State University
Certificate, 6-Sigma Black Belt
2003 — 2003
Lubar College of Business
Certificate, Strategic Leadership Series
2016 — 2016
Indiana University - Kelley School of Business
M.B.A, Business Administration
2007 — 2010
Skills
- Process Improvement
- Management
- Corrective Actions
- Warning Letter Remediation
- Fmea
- Continuous Improvement
- Cross-Functional Team Leadership
- Supplier Quality
- Iso 14971
- Iso 13485
- Dmaic
- Operational Excellence
- Leadership
- Quality Management
- Process Qualification
- Six Sigma
- Business Process Improvement
- Fda
- Purchasing Processes
- Role Mapping
- Fda Gmp
- Quality Assurance
- Supply Chain
- Quality System
- Change Management
- Process Verification
- Design of Experiments
- Manufacturing
- Medical Devices
- Capa
- Iso 9000
- Supply Chain Management
- Root Cause Analysis
- Minitab
- In Vitro
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