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Quality Engineer Resume

SUMMARY

  • Engineer with over 3 years professional experience in quality assurance, and quality control. Accomplished in creating SOPs, company policies, and document control in compliance with FDA regulations. Proficient in data analysis, complaints investigation, and conducting internal auditing.

TECHNICAL SKILLS

Programs: MATLAB, SolidWorks, LabView, Minitab

Software: Microsoft - Excel, Word, PowerPoint, Access

Languages: Python 3.0, C++, SQL

PROFESSIONAL EXPERIENCE

Quality Engineer

Confidential

Responsibilities:

  • Provided quality metrics to management, and any pertinent corrective and preventative actions
  • Train upwards of 15 employees in general inspection procedures and general quality standards
  • Coordinate objectives with production managers, quality manager, and VP of operations to maximize product quality, and reliability
  • SOP creation, CAPA procedures, OOS procedures, internal auditing

Quality Assurance Associate

Confidential

Responsibilities:

  • Created SOPs to establish company policy and procedure for manufacturing and safety on site including CAPA procedure for nonconformances and documentation
  • Led the validation for the production floor water system
  • Conducted an Internal audit to ensure compliance of FDA regulations for manufacturing
  • Ensured GLP, and GMP document compliance: created and implemented company procedure / appropriate documentation of the procedure
  • Determined sampling required for each batch produced on the production floor
  • Carried out, and documented laboratory procedures to ensure the consistency of quality for products manufactured including products containing Active Pharmaceutical Ingredients (API)

Quality Control Technician

Confidential

Responsibilities:

  • Guaranteed quality of the product through visual and empirical analysis
  • Conducted lab tests on products to determine product specifications were met
  • Preservative efficacy, pH, viscosity, emulsion stability
  • Performed clerical filing and organization

Academy Intern

Confidential

Responsibilities:

  • Provided preventative maintenance and calibration for medical devices
  • Performed inspection and inventory for diagnostic, monitoring, and therapeutic instruments
  • Verified proper operation of diagnostic, monitoring, and therapeutic instruments
  • Pathology lab (Hematology, urinalysis, and biopsies) specimen handling, and initial intake

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