Scott Maxwell

Scott Maxwell Email and Phone Number

Global Product Complaint Mangement & Regulatory Reporting | Medical Device | Pharmaceutical | Quality Systems | Compliance | Post Market Surveillance | Leadership | GMP Manufacturing | CAPA | FDA | ISO | QSIT
Scott Maxwell's Location
Clearwater, Florida, United States, United States
Scott Maxwell's Contact Details

Scott Maxwell personal email

n/a

Scott Maxwell phone numbers

About Scott Maxwell

Scott Maxwell is a Global Product Complaint Mangement & Regulatory Reporting | Medical Device | Pharmaceutical | Quality Systems | Compliance | Post Market Surveillance | Leadership | GMP Manufacturing | CAPA | FDA | ISO | QSIT. Colleagues describe him as "Scott is a very hard worker and learns quickly. He's dedicated to delivering outstanding service to his customers and it was a pleasure managing the projects we worked on together. I can recommend him unreservedly." and "Scott was a pleasure to work with and he is well respected by his coworkers. He is goal focused and you could always count on him to get the job done."

Scott Maxwell's Current Company Details

Global Product Complaint Mangement & Regulatory Reporting | Medical Device | Pharmaceutical | Quality Systems | Compliance | Post Market Surveillance | Leadership | GMP Manufacturing | CAPA | FDA | ISO | QSIT
Scott Maxwell Work Experience Details
  • Arthrex
    Quality Engineer – Product Surveillance
    Arthrex Feb 2024 - Oct 2024
    Naples, Florida, United States
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  • Compliancequest
    Eqms Senior Solution Consultant
    Compliancequest May 2022 - Dec 2023
    Clearwater, Florida, United States
    View
  • Bausch + Lomb Surgical
    Sr. Product Surveillance Specialist
    Bausch + Lomb Surgical Apr 2019 - May 2022
    Clearwater, Florida
    View
  • Ymca Of The Suncoast
    Youth Specialty Enrichment Instructor, Taekwon-Do
    Ymca Of The Suncoast Jan 2012 - May 2022
    Clearwater, Florida
    Taekwon-Do Program Instructor for ages 5+.
    View
  • Bausch + Lomb
    Sr. Product Complaint Specialist, Pharmaceuticals
    Bausch + Lomb Oct 2017 - Apr 2019
    Tampa/St. Petersburg, Florida Area
    Provide expertise in receipt, processing, monitoring and reporting of product complaints. Responsible for receiving, investigating, and responding to customer technical complaints including direct customer contact. Provide detailed status reports and associated trending. Responsible for monthly metrics of complaints. Complete all aspects of the complaint handling process, including generating and maintaining procedures and documents. Communicate effectively with customers and Consumer Affairs to obtain proper information. Respond to customers both verbally and in writing. Examine, analyze, and interpret information for investigation to determine proper conclusion and requirements for RC/CAPA issuance. Evaluate complaint investigations for completeness. Expedite any missing or incomplete parts. Assess critical complaints and determine Field Alert Reporting (FAR) applicability. Escalate critical complaints to upper management. Prepare periodic reports (daily,weekly,monthly, quarterly,annually). Summarize complaint trends and reports. Research and write special investigations for trends.
    View
  • Maetrics
    Senior Associate
    Maetrics Jun 2017 - Oct 2017
    Provide consultation on Pharmaceutical Quality System and Good Manufacturing Practice Regulations, and statutory frameworks as applicable to clients. Work within customer led deadlines to lead retrospective reviews of the client Complaints System. Identify and report on key areas of improvement and potential regulatory issues including Field Alert Reportable events. Remediate any file or record deficiencies in a uniform and timely manner. Author documentation including forms, templates, procedures etc as required for regulatory compliance of Customer’s products under the guidance of the Managing Director and/or specialists.
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  • Oscor Inc.
    Senior Complaints & Post Market Surveillance Specialist
    Oscor Inc. Feb 2017 - Jun 2017
    Palm Harbor, Florida
    Responsible for coordinating with Engineering, Manufacturing and Quality Assurance to drive activities required for investigation including failure analysis, nonconformance and CAPA. Coordinate activities related to Customer Complaint processes, Medical Device Reporting (MDR) Vigilance Reporting. Compile and analyze post market surveillance data for potential corrective action and continued improvement.
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  • Capsugel
    Qa Compliance Specialist
    Capsugel Dec 2015 - Feb 2017
    Tampa/St. Petersburg, Florida Area
    View
  • Smith & Nephew
    Quality Specialist, Complaints & Mdr Coordinator, Gbu Complaints System Administrator & Sme
    Smith & Nephew Oct 2007 - Feb 2015
    Administration of global complaint system (Pilgrim, SmartComplaints). MDR, eMDR & MDV submissions. Global eQMS configuration, script generation, testing, training and implementation (Go Live Activities)
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  • Smith & Nephew
    Production Coordinator
    Smith & Nephew Jan 2005 - Oct 2007
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  • Smith & Nephew
    Production Supervisor
    Smith & Nephew Jan 2000 - Jan 2005
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  • Smith & Nephew
    Warehouse Logistics/Materials Management
    Smith & Nephew Jan 1999 - Jan 2000
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  • Sam'S Club
    Cash Operations Supervisor, Audit Lead, Outside Sales & Marketing Representative
    Sam'S Club Jun 1995 - Aug 1999
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  • Walt Disney World
    Resorts Merchandise Lead, Trainer
    Walt Disney World Apr 1989 - Apr 1992
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Scott Maxwell Skills

Fda Medical Devices Quality Assurance Validation Quality System Capa Cross Functional Team Leadership Fda Gmp Iso 13485 21 Cfr Gmp 21 Cfr Part 11 Training Pharmaceutical Industry Manufacturing Sop U.s. Food And Drug Administration Quality Auditing Quality Control Change Control Leadership Software Documentation Capital Equipment Regulatory Affairs Product Launch Corrective And Preventive Action Quality System Compliance Cgmp Practices Design Control V&v Complaint Management Cleaning Validation Medical Device Directive Contract Manufacturing Regulatory Requirements Post Market Surveillance Sop Development Business Process Improvement Disposables Asq Iso 14971

Scott Maxwell Education Details

Frequently Asked Questions about Scott Maxwell

What is Scott Maxwell's role at the current company?

Scott Maxwell's current role is Global Product Complaint Mangement & Regulatory Reporting | Medical Device | Pharmaceutical | Quality Systems | Compliance | Post Market Surveillance | Leadership | GMP Manufacturing | CAPA | FDA | ISO | QSIT.

What is Scott Maxwell's email address?

Scott Maxwell's email address is sa****@****.rr.com

What is Scott Maxwell's direct phone number?

Scott Maxwell's direct phone number is +172748*****

What schools did Scott Maxwell attend?

Scott Maxwell attended Eckerd College, St. Petersburg College.

What are some of Scott Maxwell's interests?

Scott Maxwell has interest in Team Usa Taekwondo Fitness, Architectural Designer, San Juan 21 Sailboat, Newton's Itf Taekwondo, Professional Sports Team, Mexican Restaurant, Wayfair Professional, Community, Hemingway Rum Company, Sports League.

What skills is Scott Maxwell known for?

Scott Maxwell has skills like Fda, Medical Devices, Quality Assurance, Validation, Quality System, Capa, Cross Functional Team Leadership, Fda Gmp, Iso 13485, 21 Cfr, Gmp, 21 Cfr Part 11.

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