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Post Market Quality Engineer resume example with 4 years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
Summary

I am an innovative Quality Engineer with 4+ years of combined Premarket and Post Market experience providing cost effective solutions and resolutions to new/existing products within the Medical Device industry. My passion to assist professionals in saving people’s lives has led me to compete in the continuous improvement of Medical Devices Globally.

Skills
  • Process control documentation in MS Office,
  • Project requirement evaluation and improvement through CAD software, SAS, Minitab.
  • ISO 9000 requirements and Quality standards control
  • STAR method for troubleshooting various analytical scenarios.
  • Project Management; Establishing project goals, performing/capability analysis, and resolving issues with FMEA.
  • Design modeling, read and interpret blueprints, technical drawings, understand GD&T and computer-generated reports.
  • Understanding Design for Manufacturing perspectives to reduce lead time in attaining important fixtures.
  • Strong motivator/team player with collaborative planning, team leadership, and negotiation strengths.
  • Committed to professional development, motivated for continuous growth.
  • Assessing Non-conformance reports and understanding next steps towards complaint reduction.
Experience
Post Market Quality Engineer, 11/2019 - Current
Siemens Corporation Livonia, MI,
  • Used NPD experience in physical analysis and understanding CAD, GD&T schematics to determine root cause for test procedures on complaint field returns.
  • Represented post market Electrophysiology (EP) Quality department in Continuous Improvement and complaint reduction project. We achieved a 20% reduction in post market complaints in 2020 by utilizing root cause analysis, initiating CAPAs and NCEs, and presenting weekly to management and design to drive continuous improvement efforts.
  • Performed gap analysis in essential daily tasks. Established instruction manuals and work aids for easier adoption of team members.
  • Maintained Demonstrated commitment to patient safety and product quality by maintaining compliance and promoting a work environment that supports the Quality Policy and Quality System.

Key Accomplishments: Selected to ensure smooth transition of a $10M product acquisition by ensuring all test equipment and methods are setup prior to release date.

New Product Development Engineer, 01/2018 - 06/2019
Altra Holdings, Inc. Vista, CA,
  • Assisted in a Small team and engineered numerous development projects that were successfully captured, generating $100K-$10M annually in incremental sales.
  • Planned and coordinated presentations and processes for singular projects as well as Internal Employee engagement Plans.
  • Implemented various catheter building techniques by simultaneously creating new methods to correlate parts with schematics.
  • Investigated equipment failures by diagnosing faulty operation methods and designing 3D printed fixtures to improve efficiency.
  • Communicated sudden design/product changes with NPI Quality department to anticipate and stay up to speed with MRR’s.
  • Recognized for developing the Resistance welding settings/methods leading to an increase in new business opportunities/options.
  • Communicated eligibility to customers by conducting DOE research to assess feasibility, DFM, performance of equipment in correlated to cost
  • Successfully launched and/or helped maintain 5 new business accounts within time of employment.
  • Provided NPD support to Pre-Market Quality Engineering by communicating with purchasing departments to research suppliers with the highest quality and most reliable products.
  • Ability to take technical guidance and quality compliance from Supplier Quality throughout the NPD lifecycle on newly qualified materials/parts to assist with NPD product feasibility and implementing strategies for driving product quality and continuous improvement.
  • Closely communicated with various departments (Quality, Process, Sales, Purchasing & Material Handling, Machine Scheduling, Operations and Management) to organize proper documentation, test development status, purchase order approval, product setup/testing and Quality/Process validations.
  • NPI process documentation, as well as understand tracking system for new/current projects: New Part/Finished Good part setup, Engineering Change Notice (ECN), Special Builds, FMEA, DOE’s for product release documentation Validation, Purchase Orders/Requests, NPI Checklist (Simple/Complex).
  • Integrated quality tasks into feasibility studies by using Minitab and Microsoft Excel for DOE’s and Capability studying.
  • Involved in PFMEA studies, Internal auditing, MRB categorizing, and Validation documentation.
Angie's BOOMCHICKAPOP, 07/2016 - 07/2017
Design Engineering City, STATE,
  • Increased percentage of production by 15% designing suitable Jigs/fixtures for more efficient production flow.
  • Performed facility layout drawings using CAD based software based on client design criteria.
  • First point of contact and technical liaison for interdisciplinary teams – Quality, Coordination, and Maintenance.
  • Coordinated design reviews with cross functional engineering, regulatory and project teams.
  • Developed a documentation system for new designs with easy tracking.
  • Designed, presented, and implemented potential CAD prototypes for future prospects of business improvement
Education and Training
Bachelor of Science: Manufacturing Engineering, Expected in 05/2017
-
Minnesota State University - Mankato - Mankato, MN
GPA:
  • Minnesota State University (MSU), Mankato
  • Bachelor of Science in Manufacturing Engineering
  • Bachelor of Science in Mechanical Engineering (Junior level)
  • Cum Laude Graduate
: Mechanical Engineering, Expected in
-
Minnesota State University - Mankato - Mankato, MN,
GPA:
  • Completed most of Junior level courses
Accomplishments
  • A variety of different Wire/Tube Ablations on various types of Insulation
  • Resistance Welding NPD, translating result sub-assembly into catheter project.
  • Analysis and development of Ring welding through use of lasers, and resistance welder.
  • NPD build for Catheter, developing build techniques, establishing build order, and ensuring quality control.
  • Established project results and analysis through Microsoft Excel & Minitab 18 to determine Descriptive Statistics, Capability analysis, DOE, Defect analysis on various projects.
  • Designed Semi-Automated Kettle structure to be applied in 2019.
  • Designed new platform layout for additional conveyor line to production set by reorganizing current layout.
  • Constructed a wagon with certain standards, then tested the function using Creo 4.0
Certifications

OSHA 10-hour Construction Safety and Health

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Resume Overview

School Attended

  • Minnesota State University - Mankato
  • Minnesota State University - Mankato

Job Titles Held:

  • Post Market Quality Engineer
  • New Product Development Engineer
  • Angie's BOOMCHICKAPOP

Degrees

  • Bachelor of Science
  • Some College (No Degree)

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