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quality engineer sr resume example with 9+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
Summary

Quality Assurance Engineer A dynamic Quality Engineer with an accomplished combination of experience and education in the medical device industry. Demonstrated eight (8) successful years of participation in lean manufacturing, ISO13485, AS9100 and complaint investigations. Diligent and goal-oriented, with the skills and training to make an immediate impact in any team

Effective quality professional offering demonstrated history of superior performance in Quality Engineer roles. Frequently commended for contributions to continuous improvement and increased quality. Efficient and focused with drive for furthering [Company] mission in [Job Title] role.

Results-oriented [Job Title] adept at creating and implementing quality strategy and supervising inspections to foster conformance to company quality standards. Strong aptitude for identifying risks and implementing actionable initiatives to improve quality.

Skills
  • MS in Business Administration
  • Continuous Process Improvements
  • Cross-Functional Collaborations
  • BS in Biomedical Engineering
  • Complex Project Management
  • Additive Manufacturing Skills
  • Root Cause Analysis
  • New Product Development
  • Quality Systems
  • Quality Systems: ISO 13485, 21CFR820, Good Manufacturing Practice (GMP), Internal/External Audits, Nonconformances, Corrective and Preventative Action (CAPA), Root Cause Analysis, Complaint Management, Continuous Improvement
  • Professional Software and Applications: QT9, MasterControl, Gcode, C++ Visual, Minitab, Microsoft Office.
  • Risk Management
  • Data Analysis
  • Inspection Processes
  • PPAP Submissions
  • Six Sigma Methodologies
  • Performance Metrics
Experience
Quality Engineer Sr, 10/2015 to Current
Lockheed MartinEglin Air Force Base, FL,
  • Identified, prioritized, and implemented continuous improvement initiatives to drive year-over-year improvements to the manufacturing of precision metal tubing for medical and aerospace industries
  • Led and supported continuous improvement projects such as SMED, Kaizens, 5S events and created standard work
  • Won 2nd place Viant wide for 2020 Circle of Excellence Award for Weld Gas Optimization project
  • Actively monitor the effectiveness of processes and quality of project work with management, and propose and execute quality/process improvements
  • Core team member for ECM Salt Optimization BlackBelt project
  • Prepared and presented monthly quality metrics for quality management review and site business reviews
  • Managing validation and customer notification strategy to a multimillion dollar manufacturing cell
  • Prepared and supported site during ISO 13485, AS9100, customer audits and performed internal audits
  • Provided leadership, training and support to new Quality Engineers to expedite new employee effectiveness
  • Excellent analytical, statistical and problem solving skills with working knowledge of Data Visualization using Tableau, and Minitab
  • Extracurricular: co-leading efforts for Activities Committee to encourage associate engagement and retention.
  • Contributed to root cause evaluation to mitigate risk and foster continuous improvement.
  • Developed inter-disciplinary cross-training programs to expand competencies among employees and reduce knowledge gaps.
  • Provided spot troubleshooting of unexpected issues with products, manufacturing and design phases.
  • Drafted process documentation to standardize operating procedures and techniques.
  • Maintained ISO documents within manufacturing facilities to comply with applicable regulations.
  • Built lasting rapport with clients and vendors to foster satisfaction and loyalty.
  • Delivered training and ongoing quality assurance guidance to onsite and offshore professionals.
Lead Quality Engineer, 02/2016 to 10/2016
American EagleBridgewater, NJ,
  • Managed and developed two (2) quality control inspectors through first article, incoming, in-process and final inspections
  • Implemented and validated QMS platform, QT9
  • Utilized this software for document control, CAPAs and for manufacturing and quality management
  • Prepared and supported site during FDA Audit and resulting investigations
  • Lead and coordinated complaint and CAPA investigations and their appropriate remediation activities.
Research and Development Engineer, 05/2013 to 09/2015
Penn State UniversityUniversity Park, PA,
  • Reporting directly to the President/Owner to complete a key project: https://praxisti.com/technologies/research-development/
  • Managed additive manufacturing development of ingrowth surface for implantable medical devices
  • Utilized complex additive manufacturing techniques using MakerBot 3D Printer, C++, GCode and SolidWorks
  • Developed technologies, evaluated inspection method and measurements capabilities for stable and repetitive manufacturing of inserts
  • Trained production personnel and worked with the Process and Manufacturing Engineers to transfer new programs such as the 3D inserts into production.
  • Designed and executed experiments, analyzed and interpreted primary data and formed logical conclusions.
Education and Training
MBA: Business Analytics, Expected in 03/2020
Drexel University - Philadelphia, PA
GPA:
Bachelor of Science: Biomedical Engineering, Expected in 05/2013
University of Rhode Island - Kingston, Rhode Island
GPA:

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Resume Overview

School Attended

  • Drexel University
  • University of Rhode Island

Job Titles Held:

  • Quality Engineer Sr
  • Lead Quality Engineer
  • Research and Development Engineer

Degrees

  • MBA
  • Bachelor of Science

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