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Quality Systems Supervisor/ Section Manager Resume

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SUMMARY:

Available to discuss a challenging and responsible quality or engineering management position, where my background and experience can be fully utilized to our mutual benefit, involving process, project or manufacturing engineering, or quality engineering/ management.

EXPERIENCE:

Quality Systems Supervisor/ Section Manager

Confidential

Responsibilities:

  • Administers product release by assuring DHR integrity, generation of release documentation, and updating product status data.
  • Equipment/Facilities record QA Internal Audit functions Supervision of QS Analyst / Compliance Specialist with direct responsibility for the above activities. Direct management/facilitation of: Qualification activities (e.g. functional QC, change control, validation, etc.) Training and Competency Internal and External auditsSite - level Management of Quality Improvement Activities
  • Coordination of Quality Representative meetings and activities Direction, facilitation, and/or support of special projects Management of site level Cost of Quality Program Site level training for six sigma toolset (failure analysis, DOE, SPC, FMEA, etc.)
  • Ensures that the facility’s Quality System is established and maintained in compliance with applicable local ordinances, State statutes and Federal regulations, and other laws, including Title 21 CFR 820 (FDA Quality System Regulation Make recommendations for process improvements and participates in planning and implementing changes to manufacturing/process control requirements and the site’s associated documentation.
  • Perform performance reviews and hired personnel as required

Sr. Quality Engineer

Confidential

Responsibilities:

  • Develop annual schedule for the Internal Audit Teams
  • Developed SPC program for site
  • Track APQP Team Objectives to closure
  • Track and drive efficiency in the CAPA, SPC, APQP teams
  • Assume responsibilities of Quality Manager when out of plant
  • Train and direct team with quality tool application and planning
  • Project Engineering/ Project Management
  • Responsible for all capital projects; Project Management and status reporting of the projects.
  • Developed feasibility studies and conceptual designs
  • Developed scope and preliminary engineering leading to cost estimate and appropriation
  • Developed final engineering designs through engineering consultants and evaluated options
  • Developed required documentation
  • Prepared equipment design specifications for equipment procurement; evaluated suppliers proposals and engineering data
  • Documented system operations, including description of operation and technical procedures
  • Lead start - up planning activities; lead the execution of the start-up plan
  • Supported project team dynamics, coordination, and conflict resolution
  • Provided primary interface to operating customers for designs, training, and start-up
  • Conducted Design of Experiment on Vapor Priming System to reduce hazardous waste disposal costs and cycle time Served as lead for a Process Failure Mode Effects Analysis that reduced the defect rate for Multi-Missile Factory Hardware Utilized Statistical Process Control on Multi-Missile Factory cleaning systems, conformal coating systems, soldering and rework technologies, and hardware defects Design of Experiment(DOE)
  • Formulated a Cleaning System Design of Experiment to find optimal settings for the equipment and reduce system cycle time
  • Prepared Surface Mount Rework Station Design of Experiment to reduce defect rate

Confidential

Quality Systems Supervisor/ Section Manager

Responsibilities:

  • Supported Conformal Coating, Adhesive usage and selection, and Material Characterization activities Facilitated and led the Environmental (absorbents waste) sub team Conducted training of the proper use and maintenance of several pieces of equipment Continuous Flow Manufacturing (CFM)
  • Supported team implementing CFM strategies on an assembly line
  • Bonding, Continuous Flow Manufacturing (CFM)Surface Mount Technology(SMT) Process
  • TroubleshootingReflow Soldering & Solderability

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