Victor Stevens

Victor Stevens Email and Phone Number

Vice President, Quality and Operations at Plasma Surgical, Inc. @
Victor Stevens's Location
Atlanta, Georgia, United States, United States
Victor Stevens's Contact Details

Victor Stevens personal email

n/a
About Victor Stevens

Motivated, personable business professional with significant experience in top level management positions within Quality Assurance and Manufacturing/Operations management. Proven ability to develop, motivate, and lead diverse cross-functional and cross-cultural teams within a global environment. Creative design and strategist for the development of new programs, leading edge differentiators, and the harmonization of disparate processes. Pragmatic and reasonable in approach. Customer focused.Well organized, a team player, and not one to just accept status quo. Considered a creative thinker and someone who continually evaluates opportunities to excel the organization.Specialties: Quality AssuranceQuality Management SystemsLarge Scale Project Implementation and ManagementNew Organization Structure Development and Staff AcquisitionLeadership DevelopmentProcess Improvement - Lean, Value Stream Mapping, and Kaizen Computer System Validation (CSV)21 CFR Part 11, 21 CFR Part 820, ISO 9001, ISO 15189, ISO 13485, cGMPCertified ISO13485 Lead AuditorConsulting / TrainingElectronic / Electromechanical Manufacturing Process AutomationContract ReviewRisk IdentificationManufacturingCompliance Auditing / EvaluationVendor Capability AssessmentContract ManufacturingComplaint Handling / ResolutionCorrective Action / Preventative ActionInventory ControlEmployee EngagementBelow is a listing of large scale projects that I have personally led or have been a significant contributor towards their success. This list demonstrates my passion for working with organizations to develop new business structures and new processes and directly fit within my core competencies; Quality Assurance, Quality Systems, Large Scale Project Development and Implementation, Development of New Organizational Business Structures, Process Improvement, and Personnel Development / Training.Spare time - is there such a thing? I enjoy classic car restoration and the car show scene. This is often in support of local community charity events.

Victor Stevens's Current Company Details
Plasma Surgical, Inc.

Plasma Surgical, Inc.

Vice President, Quality and Operations at Plasma Surgical, Inc.
Victor Stevens Work Experience Details
  • Plasma Surgical, Inc.
    Vice President, Quality And Operations
    Plasma Surgical, Inc. Dec 2019 - Present
    Oversight for production, quality, and regulatory affairs functions globally. Responsibilities include global geographic business expansion, production scaling with lower cost higher quality production, and responding to ever changing regulatory requirements.
  • Plasma Surgical, Inc.
    Director, Ra/Qa
    Plasma Surgical, Inc. Mar 2018 - Dec 2019
  • Varian Medical Systems - Velocity
    Ra & Quality Systems Program Manager
    Varian Medical Systems - Velocity Aug 2015 - Mar 2018
  • Carestream Dental
    Quality Systems Manager
    Carestream Dental Jun 2013 - 2015
    Atlanta, Georgia, Us
    • Responsible for all aspects of Quality Management Systems for Dental Imaging Medical Devices• Responsible for Quality Management System compliance for two (2) Customer Support Call Centers, including Imaging Hardware and Dental Practice Management Solutions.• Certified ISO13485 Lead Auditor• ISO13485 facility certification and Quality Management Representative• CSH-Dental computerized systems validation regulatory compliance, including 21 CFR Part 11• Regulatory Inspections (ISO13485, QSR 21CFR Part 820)• Instructor for regulatory compliance and internal process and procedures• Internal Audit, Supplier Audits, Root Cause Investigations, and CAPA system• Document Control system owner, including SOP publication, periodic reviews, training, and compliance metrics• Equipment Calibration compliance, including tracking, recall, records, and external calibration suppliers
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  • Quintiles
    Executive Director, Global Quality Assurance, Central Laboratories And Cardiac Safety Services
    Quintiles Apr 2011 - Jul 2012
    Durham, North Carolina, Us
    • Responsible for all aspects of Quintiles Quality Assurance and Regulatory Compliance related to Central Laboratories and Cardiac Safety Services globally• New Process Mapping and Process Audit Program• New Lab facility set-up review team• Key member of Integration Team for new acquisitions• Process Improvement / Harmonization• Customer Complaint Evaluation and Resolution• Contract ReviewSignificant Accomplishmentso Significantly revamped the Quality Issue handling process to facilitate analysis for systemic issueso Introduced Process Audit program with process flow analysis and globally harmonized audits with an added benefit designed to identify process variabilityo Introduced Line Management monthly self-assessmentso Successfully achieved ISO 15189 Accreditation for two Quintiles Laboratories. Two additional laboratories were in process.o Successful acquisition integration of Advion laboratories within the Quintiles Central Laboratories structureo Customer Complaint Evaluation and Resolutiono cGCP certified through Barnett
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  • Quintiles
    Executive Director Qa & Head Systems Compliance Office
    Quintiles Jan 2005 - Apr 2011
    Durham, North Carolina, Us
    • QA organizational oversight responsible for all aspects of computer systems development, acquisition, validation, and implementation• Vendor Capability and Compliance Auditing, including electronic Medical Device manufacturers• Warehouse and Distribution, including facility inspection, remote storage, labeling, systems, and drug accountability• Global risk-based Vendor Management Program• Corporate 21 CFR Part 11 Compliance Office• QA Due Diligence Assessments for Potential New Acquisitions• Process Improvement / Harmonization• Customer Complaint Evaluation and Resolution• Contract ReviewSignificant Accomplishmentso Formed global Systems Compliance Office (SCO) 2005.o Developed global risk-based Vendor Management program 2007. o Developed Quintiles Certified CSV QA Professional program and successfully certified all SCO and CSV QA personnel worldwide within 2007.o Lead the development and launch of EDA (Event Driven Analysis) global QA database in 2007.o Developed risk-based approach to systems/application Periodic Review in 2009.o Key contributor in the development of a new Global Quintiles Call Center in 2009.o Expanded organization scope in 2009 to include Instruments and Equipment and subsequently developed a global harmonized Instrument and Equipment Qualification process providing the ability to leverage the initial qualification across multiple lines of business, including ECG, Phase I, and Labs. Pilot completed in 2009 with global implementation in 2010.o Recipient – Chairman’s Award 2005o Nominated for President’s Club Award 2006
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  • Quintiles
    Director / Senior Director, Quality Assurance
    Quintiles Aug 2002 - Jan 2005
    Durham, North Carolina, Us
    • Developed, maintained and enhanced quality assurance programs appropriate for Quintiles’ product ownership business, including Quintiles’ Pharmaceutical Division, Bioglan.• cGMP Contract Manufacturing Capability and product transfer • QA Due Diligence Assessments for Potential New Acquisitions and assisted with Integration as appropriate• Coordinated / Conducted Vendor Audits and/or Assessment activity• Provided support, including 21 CFR Part 11, to the corporation’s efforts to ensure that all computer systems operating in a regulated environment were properly validated.
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  • Quintiles
    Manager / Associate Director, Quality Assurance, Computer Systems Validation
    Quintiles Aug 1999 - Aug 2002
    Durham, North Carolina, Us
    • Managed the Computer Systems Validation team efforts for all Quintiles North America locations• Coordinated procedural creation and deployment regarding the CSV activities, including auditing functions• Developed and Deployed a validated Quality Management and Defect Tracking System for the purposes of coordinating all QA Americas activity including trend analysis and metrics reporting to mid and senior staff level management• Developed, coordinated and conducted training within Quintiles in the area of Computer Systems Validation and the related Core Operating Procedures• Performed QA Due Diligence Assessments for Potential New Acquisitions• Performed 21 CFR Part 11 Compliance audits, vendor audits, and process audits
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  • Honeywell Space And Aviation Systems / Tecstar
    Quality Manager
    Honeywell Space And Aviation Systems / Tecstar Apr 1988 - Aug 1999
    • Supervise Quality Organization consisting of approximately 45+ employees and supervisory staff, including Quality Engineering, Instrument and Equipment Calibration, Electronic Standards Lab, Inspection, and Test• Lead Team Member for ISO 9000 procedure development and implementation• Federal Aviation Administration (FAA) Designated Manufacturing Inspection Representative (DMIR) responsible for conducting inspections on behalf of the FAA and reporting directly to the FAA on inspection outcome. Also responsible for submitting monthly activity and metrics reports to the FAA. Required FAA recertification every 2 years.• Customer Complaint Evaluation and Product Failure and Resolution• Developed FAA approved Repair Station (obtained FAA site approval on 1st facility inspection)• Purchase Order Review / Approval• Divisional Development of the initial Quality Database including "Cost of Quality" analysis• Development of Divisional Automated tracking system for Product Failure and Corrective Action Analysis including coordination with customers• Internal Factory, External Vendor and Customer Auditing Functions• Chairman, Material Review Board and Corrective Action Board• Test Department Capability Studies and Quotes, including Manpower and Functionality• Team Member (Boeing and Lockheed), National OEM Airframe Manufacturing "Total Quality Teams"• Provide Quality Training and Support to the development of various TECSTAR personnel (both on site and off site) regarding such issues as Supplier Auditing / Surveillance and Customer Source and / or Mandated Inspections• Divisional Contact / Focal Point for Customer Audit / Surveillance, includes Space and Aircraft customers, Defense Contract Management Command, CASE, Air Carriers, FAA, and other regulatory agencies• Developed automated system for efficient tracking of employee certifications• Instructor for Soldering (NASA NHB5300 level), Workmanship, Materials Handling including Electro Static Sensitive devices
  • Honeywell Space And Aviation Systems
    Progressive Management Positions (See Other Sections For Specific Roles)
    Honeywell Space And Aviation Systems 1980 - 1999
    Charlotte, North Carolina, Us
    Experienced in Manufacturing Operations and QA management for the manufacture of electronic and electromechanical navigation and control type devices for commercial, defense, and space avionics. This included assembly production, manufacturing methods (JIT, Demand Flow, and the use of Kanban), Quality Control and Inspection processes, testing / diagnostics, failure analysis, Engineering Change Order (ECO) reviews, Quality Engineering, contract manufacturing, and supplier (vendor) capability assessments / auditing.Additional skills: Material Planning and Production Control, including vendor contract review, product review for suitability, vendor capability, contract manufacturing, and risk-based vendor management. Electronic Requirement Planning (ERP) systems for evaluating the bill of materials, product requirements, lead time, stock availability, perishable materials, stock rotation, stock turnover rates, and establishing effective reorder points. Nonconforming materials and the Material Review Board process (MRB) for handling and processing defective material.See other sections for detailed roles.
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  • Honeywell Space And Aviation Systems (Formerly Sperry Flight Systems)
    Manager, Electronic Assembly And Production Control
    Honeywell Space And Aviation Systems (Formerly Sperry Flight Systems) 1983 - 1988
    • Managing Production Control, Inventory, and Production Staff consisting of 60+ employees, including supervisory staff• Transition new designs from Product Engineering to full Production• Member of Divisional Staff level Cost Reduction Program• Manufacturing Capability Studies and Quotes• Process Improvement utilizing tools such as JIT, Demand Flow Technology, Takt• Introduction, Development and Implementation of employee team building practices• Electronic Manufacturing Department Coordination, Manpower and Functionality• Employee orientation and training employees for new positions• Establishing Time Standards and evaluating Production Performance• Analyzing Tooling Requirements and Development of Specialized Fixturization• Management of Inventory Control including; Stock Rotation, Perishable Material, Reorder Point, and Cycle Count• Contract Review and Negotiation• Purchase order generation, review, and approval
  • Honeywell Space And Aviation Systems (Formerly Sperry Flight Systems)
    Supervisor, Production Control And Technical Assistant
    Honeywell Space And Aviation Systems (Formerly Sperry Flight Systems) 1980 - 1983
    Progressive positions with responsibilities in the following areas:• Supervising 20+ employees and assisting other production supervisors where needed• Interpretation of Technical Documents• Responsible for generating parts coverage utilizing MRPII and hybrid ERP inventory control systems• Updating computerized Bill of Materials (BOM)• Loading jobs to various departments and coordinating schedules between departments• Master Production Scheduling• Implementation of a computer generated release system within the Motor Assembly Dept• Designing and Building Test Equipment

Victor Stevens Skills

21 Cfr Part 11 Quality Management Process Improvement Computer System Validation Quality Assurance Vendor Management Clinical Trials Manufacturing Auditing Root Cause Analysis Iso 9000 Erp Quality Systems Design Employee Engagement Inventory Control Systems Analysis Metrology Cmmi Iso 15189 Problem Solving Process Mapping Quality Assurance And Quality Control Compliance And Regulatory Analysis Effectiveness Checks Aerospace Manufacturing Lean Methodology Mentor Cross Functional Team Development And Coaching Training And Certification Development And Instruction Diagnostics Intrument And Equipment Qualification Process Harmonization Vendor Evaluation And Auditing Systems Development Electronic Device Manufacturing Electronics Systems Manufacturing Environmental Testing And Failure Analysis Schematic Interpretation Non Conforming Materials Review Materials Handling Manufacturing To Nasa Specifications Pre Cap Inspections For Manned Space Flight Product

Frequently Asked Questions about Victor Stevens

What company does Victor Stevens work for?

Victor Stevens works for Plasma Surgical, Inc.

What is Victor Stevens's role at the current company?

Victor Stevens's current role is Vice President, Quality and Operations at Plasma Surgical, Inc..

What is Victor Stevens's email address?

Victor Stevens's email address is vs****@****cal.com

What skills is Victor Stevens known for?

Victor Stevens has skills like 21 Cfr Part 11, Quality Management, Process Improvement, Computer System Validation, Quality Assurance, Vendor Management, Clinical Trials, Manufacturing, Auditing, Root Cause Analysis, Iso 9000, Erp.

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