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Quality Engineer Resume

Valdese, NC

SUMMARY

  • As a Quality professional, I am experienced in development, implementation and execution of improved processes and techniques for various industries such as Aerospace, Polymer and Pharmaceutical, Medical Devices etc. with expertise in analysis, interpretation, problem solving and regulatory requirements for cGMP, ISO/QS/TS, and FDA.

PROFESSIONAL EXPERIENCE

Quality Engineer

Confidential, Valdese, NC

Responsibilities:

  • Created and Implementation of FMEA failure mode analysis for Cell Assembly Process.
  • Created and implemented Reaction plans and Control plan for process.
  • Investigate process issues using brainstorming and PDCA.
  • Used statistical methods as appropriate to establish sampling plans, determine process capability and implement control charts and conduct inspections (Minitab). Educate others on quality tools and principles.
  • Analysis of cell and battery performance data, processing measurement data for special cause conditions and implement corrective actions.
  • Gauge R&R study for quality checks.
  • Use of Lean tools like 5S, OEE, Kanban, Value Stream Mapping, Visual Factory, in process.
  • Train, develop, and monitors SPC knowledge on the shop - floor. (administer the Shop Floor-Light House system)
  • Worked with Product Engineer on PPAP for supplier qualification.
  • Designing and implementing experiments to assist with process optimization, problem resolution and new process development.
  • Participate in internal audits and Work with audit team to make systems/processes more effective.
  • Containment and Corrective Analysis (8D and FA) of customer returns as well as internal non-conforming materials. Assist Customer Service team with complaint resolution.
  • Containment and Analysis of supplier non-conforming materials. Assist Purchasing in complaint resolution.
  • Provides routine analysis of performance indicators (kpi). Presents this information to management.

Sr. Chemist

Confidential, Piedmont SC

Responsibilities:

  • Routine analysis of chemical product using various instruments like GC, HPLC, GPC, DSC, FT-IR, Titrando Autotitrator, Coulometer and Volumetric KF, Brook field viscometer, Viscotek etc for Raw Material, In Process, and Finish Product
  • Preparation of lab batch for R&D
  • Regularly Calibration and Maintenance all laboratory instruments.
Quality Engineer

Confidential, Piedmont SC

Responsibilities:

  • Provided supervision, leadership and technical issue resolution to QA
  • Daily monitoring of QA data for Raw Material, In-Process and Finished product test result.
  • Routinely prepare SPC Charts using JMP software for Green Belt level process improvement.
  • Worked on Root Cause Analysis using FMEA, MSE on existing Laboratory Methods to solve the permanent issue.
  • Developed new Experiment for Process and R&D
  • Developed new analytical methods for Tests for QA and R&D Laboratory for process development.
  • Regularly maintenance, calibration, and troubleshooting of all Laboratory instruments like HPLC, GC, GPC, UV-VIS, Auto-titrator, ASC Extractor, Brookfield Viscometer, Refractometer etc.
  • Work with Vendors and Raw Material Suppliers to drive Quality improvement and new product development as needed.
  • Wrote SOP and training Documents per TS16949.

Product Development Chemist

Confidential, Greenville SC

Responsibilities:

  • Develop Analytical Methods for ANDAs, conduct API and Stability testing (characterization and forced degradation studies) using HPLC, GC, UV-VIS, FTIR, AA etc per FDA regulations.
  • Document and execute Method Validation for APIs and New Products.
  • Work with Validation Department for IQ, OQ, PQ.
  • Documentation for Regulatory Requirements for ANDA submissions.
  • Documentation and Review of Standard Operating Procedures.
  • Execution and Documentation of Cleaning Validation and Hose Studies.
  • Inter-Lab Method Transfer of New Analytical Methods.
  • Laboratory OOS investigations, participation and technical support using CAPA.
  • Supplier Qualification

Quality Assurance Chemist

Confidential, Greenville SC

Responsibilities:

  • Maintained compliance to cGMPs, FDA and internal quality systems.
  • Performed internal audits, In Process Control, and Conducted Finish product release.

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