Steven McQuillan
Executive Leadership, Mentor and Advisor in MedTech
- Role
- Chief Clinical, Regulatory and Quality Officer at Argá Medtech Sa
- Location
- Naples, FL, US
- LinkedIn followers
- 500 followers
About Steven McQuillan
Experienced Vice President Of Quality with a demonstrated history of working in the medical device industry. Skilled in Verification and Validation (V&V), Medical Devices, Good Clinical Practice (GCP), Biotechnology, and Biomedical Engineering. Strong quality assurance professional with a BA x 2 focused in Engineering Statistics and Biostatistics from University of Minnesota-Twin Cities.
Experience
Chief Clinical, Regulatory and Quality Officer
Apr 2024 — Present · San Diego, CA, US
Leading a team of top Pulsed Field Ablation Experts through the regulatory process of governmental medical device approval
Education
University of Minnesota
BA x 2, Engineering Statistics and Biostatistics
1980 — 1985
Skills
- Fda
- 510 K
- Medical Devices
- Design Control
- Pma
- Clinical Trial Management
- Clinical Research
- Clinical Trials
- Regulatory Affairs
- Ctms
- Gcp
- V&V
- Quality System
- Biostatistics
- R&D
- Biomedical Engineering
- Iso 13485
- Cardiology
- Commercialization
- Healthcare
- Clinical Development
- Biotechnology
- Protocol
- Cross-Functional Team Leadership
- Validation
- Regulatory Submissions
- Sop
- Pharmaceutical Industry
- Capa
- Product Launch
- U.s. Food and Drug Administration (Fda)
- Research and Development (R&D)
- Good Clinical Practice (Gcp)
- Clinical Trial Management System (Ctms)
- Corrective and Preventive Action (Capa)
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