quality engineer resume example with 4+ years of experience

Jessica Claire
Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000 - Cell: - - : - -
Professional Summary

• Skilled Validation Engineer in FDA-regulated environment with numerous years of medical device experience; and applied understanding of ISO 13485 and 21 CFR Part 820 - Quality System Regulation (QSR).
• Hands-on experience in various medical devices and systems (class II, III), development, manufacturing, new product introduction, process validation, computer software validation, compliance/ quality/ remediation.
• Experience with FDA product development documentation: DFMEA, V&V, DHF, DMR, NCMR.
• Skilled in problem solving techniques involving Lean/Six Sigma statistical tools such as: Minitab, MatLab, SolidWorks, Pro-E; 2D and 3D modeling experience.
• Expertise in writing and executing process validation protocols, including IQ, OQ, and PQ protocols, Test Method Validation (attribute and variable), SOPs, Laboratory Investigations, Global Change Controls.

  • Non-conforming materials process
  • Inspection methods
  • Process change documentation
  • Non-conforming material reports
  • Root cause analysis
  • Good documentation practices
Work History
03/2018 to Current
Quality Engineer Emd Millipore Burlington - All, CA,
  • Built strong rapport with team members, management and clients to facilitate efficiency and productivity
  • Collaborated with management and inspectors to ensure adherence to quality standards
  • Responsible for Participating in the development and execution of process and equipment validation protocols
  • Providing support to Quality processes such as Non-Conformance, CAPA, Change Management, Audits
  • Assist in performing Tests and calculating acceptance criteria for tests
  • Assist in root cause investigation of statistical or test failures
  • Developing, troubleshooting, and refining medical-device manufacturing processes and equipment
  • Arranging team meetings on a daily and weekly basis for status updates on the project
  • Designing fixtures/tools for ergonomic improvement to the process
  • Maintained and help improve assembly lines by implementing Lean and Six Sigma techniques.
07/2018 to 02/2019
Validation Engineer The Kemtah Group Warren, MI,

• Responsible for the Computer Software Validation efforts for the Getinge and Belimed Autoclaves used in the sterilization process.
• Developed Software validation protocol for the Automated Tissue fixation system for tissue Processing used in the manufacture of Heart Valves.
• Developed Process validation plans, protocols, and reports associated with Installation Qualification, (IQ), DOE, Gage R&R, pFMEA, Operational Qualification (OQ), Performance Qualification (PQ) and Master Validation Reports (MVR).
• Developed IQ,OQ and PQ protocols for NIKON iNEXIV VMA-4540 automatic measuring system
• Developed Test Method and process Validation protocols and reviewed the Design History Files (DHFs).

07/2016 to 07/2017
Validation Engineer The Kemtah Group Agawam, MA,
  • Identified causes of equipment failures and made suggestions for issue resolution
  • Explained highly complex information in terms easily understood by non-technical personnel
  • Documented entire validation process, noting changes or alterations completed
  • • Responsible for the Computer Software Validation efforts for the tubing manifold of the next generation vitrectomy probe.
    • Participated in laboratory studies to evaluate value and appeal of new product features.
    • Conducted successful design review with R&D, manufacturing and console team to ensure design is ready to proceed with proof of concept.
    • Conduct Gage R&R studies to quantify the robustness of the design.
    • Generated statistical analysis using Minitab for setting up production test limits with Six Sigma tolerance.
    • Developed Test Method and process Validation protocols and reviewed the Design History Files (DHFs).
    • Verified the Reproducibility and the Repeatability of existing processes and gages through Variable and Attribute Test Method Validation(TMV).
    • Negotiated tooling and schedule development with injection molders to ensure prototype subassemblies can be provided for testing to meet verification and validation milestone.
    • Created CAPA and design control systems and developed methods to resolve issues related to non-conformances by coordinating with receiving and production departments.
    • FDA 510(k) Submission: Composed 510(k) submission documents for a new less invasive retina instrument set.
    • Applied Lean manufacturing techniques to continuously improve process flows. Performed analysis verification of design. Utilized continuous improvement tools (Lean Six Sigma) to improve process robustness and capability.
    • Managed design of experiments (DOEs) with manufacturing team and vendors to determine root cause of weak engine bond failures, reducing risk of catastrophic surgical failures.
    • Design Verification and Validation (V&V) Engineering: Created Product and Design Specification as part of capturing technical requirements to be validated.
    • Collaborate investigations with engineering, Clinical Applications Specialists, Supplier Quality and support various departments to complete complaint analysis and compile investigation results.
    • Created or reviewed PFMEA, IQ/OQ/PQ/PPQ protocols and reports, analyzed test results, communicated findings and got approvals across all functional teams involved
Expected in 12/2015 to to
Master of Science: Mechanical Engineering Technology
University of North Texas - Denton, TX

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Resume Overview

School Attended

  • University of North Texas

Job Titles Held:

  • Quality Engineer
  • Validation Engineer
  • Validation Engineer


  • Master of Science

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