Post Market Quality Engineer resume example with 4 years of experience
JessicaClaire
, , 609 Johnson Ave., 49204, Tulsa, OK100 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
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