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Sr. Quality Engineer Resume

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Irvine, CA

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SUMMARY:

I'm a mid - level Quality / Process Engineer who solves ongoing Process non-conformances issues at client sites to return them back to sustained growth. My past projects have increased my clients’ profits by improving process yields while reducing the costs of scrapped goods, project overruns and frequent resource turnovers

SUMMARY OF EXPERTISE:

Quality Mgmt Systems: Change Controls, Risk Management (FMEA), NCRs, CAPAs, Internal and External Audits, Lean Six Sigma Methodologies

Design Control: Risk Management ( DFMEAs), D HF deliverables, CE Technical Files, Design Changes.

Pharmaceutical and Med Device Regs: 21 CFR 11, 21 CFR 210, 211, 820, ISO 13485 & 14971, ISO 10993, ISO 14644, ISO 17025, ISO 14001, ISO 11979, GAMP V, G LP.

Process Controls: Batch Records, SPC/SQC, In-process inspections, Rework

Qualifications (CQ, IQ, OQ, PQ, SWV): PLCs / SLCs ; Material Analyzers; Vision Inspection Systems; Temperature, Pressure and Humidity monitoring devices; Tensile, Compression & Torque testers, Catheter and Stent testers, WFI /DI Water systems with SCADA monitoring; Stability Chambers, Tissue Treatment Units, Autoclaves; Enterprise Systems - Proficient SPC, Calibration Manager, Gage InSite, Trackwise, Agile, Documentum, Stability Laboratory Information Management, Empower, Building Management System, Environmental Alarm Monitoring System; Programming - C++, Fortran, Basic, RSLogix & RS View; Lab Systems - AAS, UV/VIS, FTIR, HPLC & GC Spectrometers Software Proficiency in - Windows, UNIX, MAC OS, MS Office .

Test Method Validation: Attribute & Variable TMV s, DOE, Statistical Analysis (t - test, ANOVA, Chi Square), Statistical Software (JMP, Minitab, Matlab, Maple, R)

PROFESSIONAL EXPERIENCES:

Confidential, Irvine, CA

Sr. Quality engineer

Responsibilities:

  • Doing Root Cause analyses, verifying / validating the root causes, evaluating the processes after the fixes were implemented and revising the Confidential documents. This was done by:
  • Corrective and preventative fixes to re-occurring non-conformances
  • Changing a culture of firefighting to one where continuous improvement was embraced
  • Better retention of manufacturing resources with a focus on improving growth.

Confidential, Orange, CA

Sr. Chemical Engineer

Responsibilities:

  • Improved this process by centering the process distribution and proposing better rework instructions
  • The improvement saved the company $1.35M in cost and improved the process capability.

Confidential, Carlsbad, CA

Sr. Quality Engineer

Responsibilities:

  • Validating and generating procedures for this new electronic data management system
  • This system eliminated 9 out of 10 in-process inspections due to real time process monitoring
  • It also doubled the output from each product line

Confidential, Aliso Viejo, CA

Test Laboratory manager

Responsibilities:

  • Receive, calibrate and qualify the instruments and equipment needed in the surgical lab
  • Manager the flow of material and availability / procurement of equipment needed to perform testing on surgical products in the lab
  • The new lab was up and running in a month, handling the same volume as the old lab using a 3rd of the space

Confidential, Warsaw, IN

Quality Engineer

Responsibilities:

  • By analyzing past batch records, working with the technicians to reduce appraiser variation and reducing equipment variation we successfully run several Confidential and standardized how Test Method Validations were executed.
  • This increased the first pass yield on Test Method Validations.

Confidential, Temecula, CA

Reliability Engineer

Responsibilities:

  • Overseeing the Calibration and PM program for the test instruments in the lab
  • The upgrade of the lab data recording system from a "pen and paper" system to a LIMS system
  • This eliminated the 48-hour turnaround time and transcription errors related to data recording

Confidential, Corona, CA

Computer Systems Validation (CSV) Engineer

Responsibilities:

  • Creating CSV procedures and delineating them from Equipment Qualification procedures
  • Creating robust Validation URS, FRS, TM, IQ, OQ and PQ Protocol templates
  • We as a department were then able to perform multiple successful validations which were audited by the FDA with zero findings.

Confidential, Indianapolis, IN

CSV Engineer

Responsibilities:

  • I performed gap assessments and remediated the lacking / non-existent deliverables to ensure a complete validation package on their lab, PLC and DCS systems.
  • This initiative led to better informed and prepared Lilly sites during compliance audits.

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