quality engineer resume example with 3+ years of experience

Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000,
  • Oracle Agile ECO system (Exception Report and Document Control)
  • CAPA resolution and coordination
  • CAD experience (Inventor 2019)
  • Trackwise quality system
  • ISO 134885:2016, ISO 22442-2:2015 and 21CR820
  • Design review experience (DFMEA)
  • Clean Room Environment Experience
  • ERP software experience (SAP and SAGE)
  • Excellent problem-solving abilities
  • Root cause analysis (Ishikawa, Pareto, FMEA)
  • Continuous improvement
  • Excellent communication and teamwork skills
  • Knowledge of Mexico work environment and culture
  • Fluent in Spanish, 95% written, 95% Read
  • Non-Conforming Material Reports
  • Process Optimization
  • Root Cause Analysis
Professional Summary

Industrious Quality Engineer offering 3 years of positive experience in related roles. Highly skilled in devising quality improvement strategy and evaluating current processes implement improvements. Focused and diligent with a commitment to fostering Edward's mission of helping patients and their families to live longer, healthier and more productive lives. Assertive professional possessing outstanding management, interpersonal and organizational skills in the improvement and resolution of CAPAs, design related activities and quality system coordinator. Highly valued by cross-disciplinary teams for implementing actionable initiative that reducing overdue CAPAs from 58% to 10% in 6 months and optimizing company processes while maintaining a quality-focused mindset.

  • Certified Six Sigma Green Belt
  • QMS ISO 13485:2016 Course
  • Yellow Belt Problem Solving
  • Non-conformance Report Course
Expected in 12/2016 to to Bachelor of Science | Biomedical Engineering The University of Iowa, Iowa City, IA GPA:
Work History
10/2019 to Current Quality Engineer American Axle & Manufacturing | Twinsburg, OH,
  • Directed Test Method Validations for proposed quality controls performing necessary Risk Analysis and Gauge R&R study to evaluate results and update risk priority numbers.
  • Assumed responsibility as CAPA and NCMR interim Quality system owner while vacancy is being filled
  • Spearheaded over 15 corrective and preventive actions as quality system coordinator including resolution of 2 quality hold with and 1 Field Corrective Action, adhering to company and regulatory standards.
  • Collaborated with cross-disciplinary team in creation and review of design related files for new product introduction
  • Participated as quality representative in review of new product DFMEA by helping identifying potential failure modes with risk, causes, establishing design controls and assign risk priority levels
  • Worked with cross-disciplinary team to resolve high priority items in timely and accurate manner resulting in completion of 2 projects related to product launching activities.
  • Reviewed IOPQ documentation assuring alignment with company quality standards and ISO regulations
  • Mobilized site management to participate in a series of coordinated activities that sharply reducing percentage of overdue CAPAs from 58% to targeted 10% in 6 month period
  • Administered monthly and annual reviews to assess NCMR and CAPA quality system metrics to management
  • Revitalized project to establish stable monthly CAPA Review Board meetings with stakeholders to increase visibility of issues related to CAPAs and maintained constant stakeholder participation
  • Participated in ISO audit as CAPA and NCMR system owner participating in discussion with auditors
  • Promote quality focused Kaizen ideology to manufacturing personnel to solidify quality culture and clarify importance of 5's in workstations
  • Perform sustaining product activities on chemical/solution based production and product assembly lines.
  • Facilitated and bridged communications between Quality and other depratments
11/2017 to 10/2019 Quality Engineer American Axle & Manufacturing | North Vernon, IN,
  • Perform sustaining product activities on Medtronic Sewing department for a year with focus on Endurant Stent Grafts and some exposure to Tri-Ad Annuloplasty.
  • Driven multiple corrective and preventive actions with 4 requiring high level leadership to accomplish project closure, establishing recurrence control, identifying necessary resources and clearing roadblocks
  • Perform sustaining product activities on initial launch of new transferred product (debut launch and after-transfer sustaining) with designated cross-disciplinary support team
  • Supervise team of 5 quality control personnel who verify products, audit production lines, and verify documentation, working in tandem to monitor and increase production quality
  • Reviewed and approved more than 10 Installation Qualification and 2 Operation and Process Qualification validations reports assuring alignment with company quality standards and ISO 9000 regulations
  • Perform sustaining product activities on multiple catheter products with focus on stent delivering subassembly
  • Manage inventory movement through SAP ERP system, creating inspections lots and quarantining conforming material for evaluation and follow up disposition
  • Participate in monthly and annual reviews to assess product performance and present product quality metrics to management
  • Demonstrate product and quality expertise in product inspections allowing to accurately and efficiently handle special cause variation
  • Assumed responsibility of NCMR and CAPA Quality Coordinator as interim during the filling of the position
  • Reduction of OVerdue CAPAs from 58% to 10% in 6 months
  • Explained risk management strategies to management staff which enabled issues to be resolved prior to project implementation, preventing the waste of valuable resources
  • Coordination of weekly team meetings as lead, improving communications and better overall work relationships among project and sustaining personnel
  • Used Microsoft Excel to develop quality tracking spreadsheets and automated graphical outputs for a more visual representation of data
  • Worked in tandem with multiple departments, including calibration, IT, and SAP specialized to resolve the use of tools with expired calibration by implementing and documenting an audit process control reducing incidents from over 2 a month to 0. This reduced the risk of using an expired equipment on a product and helped pave the road for the integration of an in-line equipment verification system
  • Participated in the successful commercialization of a transferred product from a sister production site and performed hypercare to assure product quality

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Resume Overview

School Attended

  • The University of Iowa

Job Titles Held:

  • Quality Engineer
  • Quality Engineer


  • Bachelor of Science

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