Brent Croft

Brent Croft Email and Phone Number

Vice President Of Quality & Regulatory at Spark Biomedical Inc @ Spark Biomedical Inc
Brent Croft's Location
Dallas-Fort Worth Metroplex, United States, United States
About Brent Croft

Focused and caring leader with proven history of closing challenging product development programs. My experience is grounded in a broad technical acumen and intuition, refined employee engagement and leadership skills, organization structure and team leadership - both functional and cross-functional program teams. I am a polished professional who values personal accountability. My management style is best described as collaborative leadership. I have been recognized for communication at all levels of business, including executive, both internal and external.My peers and executives regard me as a hands-on leader who values employee engagement, autonomy, accountability, and open communication; encourages individual development, pursuing personal challenges, and continued professional development. Key Competencies: Systems EngineeringProject and Program ManagementProduct Design, Product Development and Product LaunchRegulatory Compliance - FDA, EPA, TUV, BSI and othersContinuous Process Improvements – ISOService Delivery, Development, and Enhancement – ITIL Team Building and Change Management Policies and ProceduresStrategic and Operational PlanningProduct Research and Technology Development (R&D)Troubleshooting and Problem SolvingUnderstand Complex Scientific and Technical InformationLogic and Scientific ThinkingEmployee Engagement and RetentionRisk Assessment and Risk AvoidanceBudget, Cost and Internal ControlsClient Relations and RetentionVendor and Outsourcing LiaisonClinical Analysis and InformaticsIndustry Research and Competitive AnalysisContract and Agreement NegotiationsCommunicatorNegotiatorDedicatedAnalyticalFlexibleMulti-Tasking

Brent Croft's Current Company Details
Spark Biomedical Inc

Spark Biomedical Inc

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Vice President Of Quality & Regulatory at Spark Biomedical Inc
Brent Croft Work Experience Details
  • Spark Biomedical Inc
    Vice President Of Quality & Regulatory
    Spark Biomedical Inc Mar 2020 - Present
    Dallas, Texas, Us
    Implement and maintain a ISO 13485:2016 and MDSAP compliant quality system.Support R&D and Regulatory processes to achieve 510k clearance.Support design transfer to manufacturing, and supplier management.Implement compliant field surveillance processes in support of the market launch.
  • Heartsciences
    Principal System Engineer
    Heartsciences Jan 2016 - May 2020
    Southlake, Texas, Us
    Responsible for most R&D design controls documentation - User Needs, Design Inputs, Risk Management, Cybersecurity, Usability Engineering & Human Factors (Use Specification, UI Specification, HF Evaluation Plan, Formative and Summative Testing), System Integration and Exploratory Testing, Design Verification (Plan, Test Protocols, Execution, and Reports), Design Validation, Usability Testing, Basic Safety, System Trace, Test Automation, EMR Interface/Interoperability.
  • St. Jude Medical
    Sr. Mgr. Systems Engineering
    St. Jude Medical Mar 2012 - Dec 2015
    St. Paul, Minnesota, Us
  • St. Jude Medical, Neuromodulation Division
    Software Analyst Manager
    St. Jude Medical, Neuromodulation Division Jun 2011 - Oct 2012
    Held this position simultaneously with Sr. Mgr. Systems Engineering position listed above
  • T-System
    Solution Manager
    T-System Sep 2009 - Jun 2011
    Plano, Tx, Us
  • T-System
    Manager, Data Services
    T-System Mar 2009 - May 2011
    Plano, Tx, Us
    Held this position simultaneously with Solution Manager position listed above.
  • Hotels.Com
    Release Manager
    Hotels.Com Nov 2008 - Feb 2009
    This transition and new role resulted from organizational changes brought on by a new CIO.
  • Hotels.Com
    It Service Program Manager
    Hotels.Com Sep 2008 - Oct 2008
  • T-System
    Specialist, Clinical Data Initiatives
    T-System Mar 2008 - Sep 2008
    Plano, Tx, Us
  • Perot Systems Corporation
    Manager - Level 3 Clinical Quality Application Support
    Perot Systems Corporation Jul 2007 - Mar 2008
  • Perot Systems
    Technical Team Lead
    Perot Systems May 2005 - Mar 2008
    Round Rock, Texas, Us
  • Revenue Technology Services
    System Engineer
    Revenue Technology Services Feb 2000 - May 2005
    Plano, Texas, Us
    During my last 2 years as a system engineer, I saved RTS $100k - 6.25% of the total company operating budget of $1.6M. Projects completed to realize this savings include: software license compliance program, internalization of key network services, implementation of corporate spam and virus protection, and upgrades to our international WAN.Responsibilities included business continuity planning, vendor management, RFP and bid management, procurement, server and desktop support.
  • Revenue Technology Services
    Software Developer
    Revenue Technology Services Feb 2000 - May 2005
    Plano, Texas, Us

Brent Croft Skills

Cross Functional Team Leadership Leadership Management Process Improvement Medical Devices Vendor Management Software Documentation Sdlc Software Development Fda Business Intelligence Project Management Itil It Management Systems Engineering Design Control Requirements Analysis Strategic Planning Product Development Software Project Management Team Building Product Management Outsourcing System Requirements Systems Engineering Process Medical Device R&d Neuromodulation Capa Microsoft Sql Server Ssrs Spinal Cord Stimulation Requirements Traceability Change Management Requirements Management 21 Cfr Class Iii Medical Devices Capas Data Warehousing Business Process Improvement U.s. Food And Drug Administration Inspection Voice Of The Customer Business Travel

Brent Croft Education Details

  • Devry
    Devry
    Information Systems
  • Naveen Jindal School Of Management, Ut Dallas
    Naveen Jindal School Of Management, Ut Dallas
    Mba

Frequently Asked Questions about Brent Croft

What company does Brent Croft work for?

Brent Croft works for Spark Biomedical Inc

What is Brent Croft's role at the current company?

Brent Croft's current role is Vice President Of Quality & Regulatory at Spark Biomedical Inc.

What is Brent Croft's email address?

Brent Croft's email address is bc****@****ail.com

What is Brent Croft's direct phone number?

Brent Croft's direct phone number is +197221*****

What schools did Brent Croft attend?

Brent Croft attended Devry, Naveen Jindal School Of Management, Ut Dallas.

What skills is Brent Croft known for?

Brent Croft has skills like Cross Functional Team Leadership, Leadership, Management, Process Improvement, Medical Devices, Vendor Management, Software Documentation, Sdlc, Software Development, Fda, Business Intelligence, Project Management.

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