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:

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