Steven Allison
Senior VP Quality & Regulatory | Global Regulatory Affairs
- Role
- Senior Vice President Quality & Regulatory at Drive Devilbiss Healthcare
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Steven Allison
As a Sr. Vice President of Quality and Regulatory, I am responsible for all global quality and regulatory activities for the company\'s operations, including manufacturing, design, and distribution of class I and II durable medical equipment and respiratory products. With over 20 years of experience in the field, I am a transformational leader, strategic thinker, skilled communicator, team builder, and adept negotiator who blends expertise in global regulatory affairs and quality management with exceptional skills in business development and operations management.My core competencies include FDA (QSR) Quality Systems, ISO 13485/ISO 14971 Risk Management, and Strategic Programs. I have successfully led the implementation of a global Quality Improvement Program (QIP) that addressed the core elements of the QMS, such as CAPA, Complaint Handling/Trending, Training, Medical Device Reporting (MDR), Design Controls, and Design Transfer. I have also spearheaded the update of the QMS and Technical Files to comply with the IVDR requirements, and established collaborative working relationships with manufacturing, R&D, and various business partners. My mission is to position quality as a competitive business advantage, while ensuring regulatory compliance and product quality. I am passionate about driving cultural transformation and change management, and empowering my global team of over 400 quality professionals.
Experience
Senior Vice President Quality & Regulatory
Jan 2023 — Present · New York, NY, US
Responsible for all global quality and regulatory activities for the company’s operations including, manufacturing, design, and distributing of class I and II durable medical equipment and respiratory products. Responsible for quality operations, quality systems, and regulatory affairs across the Company, including corporate headquarters as well as domestic and international manufacturing sites and distribution centers. Transformational leader, strategic thinker, skilled communicator, team builder, and adept negotiator who blends expertise in global regulatory affairs and quality management with exceptional skills in business development and operations management.
Education
University of Michigan
MBA, Business / Manufacturing Operations
2007 — 2010
Liberty University
Doctor of Philosophy - PhD, Strategic Leadership
2023
Binghamton University
BS, Industrial Manufacturing Technology / IT
1991 — 1994
Skills
- Clinical Trials
- Quality System
- Quality Systems
- V&V
- Cmmi
- 21 Cfr
- Lean Manufacturing
- Internal Audit
- Quality Control
- Gmp
- Quality Assurance
- Corrective and Preventive Action (Capa)
- Testing
- Pharmaceuticals
- Regulatory Requirements
- Cglp
- Six Sigma
- Gxp
- Quality Auditing
- Validation
- Cgmp
- Team Leadership
- Software Quality Assurance
- Change Control
- Dmaic
- Iso 13485
- Root Cause Analysis
- Cqa
- Quality Management
- Cross-Functional Team Leadership
- Computer System Validation
- Iso 14971
- Medical Devices
- Capa
- Iso 9000
- Iso
- Software Quality Management
- Pharmaceutical Industry
- Sop
- Fda
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