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Skills

  • CAPA (Corrective and Preventive Action) Management
  • Team building
  • MS Office
  • Failure analysis of complex systems
  • Invoice generation
  • Organization
  • Team management
  • Supervision
  • Designing Tableau
  • Schematic reading

Work Experiences

  • Achieved Scrum Master certification.
  • Aligned with design inputs.
  • Learned budget management and project management to help with office needs.
  • Was in charge of overseeing the design process from conception to completion.
  • Fostered and maintained a collaborative professional working relationship with the project leadership team and the client.
  • Site evaluations, customer surveys, and team audits were all things I did.
  • Worked with others to brainstorm new system possibilities.
  • Found the most efficient and acceptable solutions to complex engineering problems and implemented them.
  • Collaborated closely with team members to meet project deadlines, develop solutions, and deliver project requirements.
  • Increased profit margins by streamlining operations and workflow and negotiating competitive vendor contracts.

Summaries

  • Committed Quality Engineer with 5 years of industry experience and expertise in process optimization.
  • Goal-oriented system Engineer who can work under pressure and with limited resources to create innovative designs that meet and exceed goals.
  • Lean certified
  • Ability to recognize procedure issues and integrate standard solutions to achieve category.
  • Achieved Employee of the Year in 2019.
  • Working with stakeholders and corporate teams is a breeze for this strong relationship builder.
  • Design Assurance Engineer and team leader with 15 years of experience in procedure settings.
  • Accomplished at performing gap analyses on existing products to align with updated standards, preventing regulatory delays and expediting market readiness for Cedar Works.
  • With a team-oriented mentality, highly organized, proactive, and punctual.
  • Achieved a 36% decrease in quality control issues.

Accomplishments

  • Authored technical design input documentation that enhanced compliance with FDA regulations, ensuring first-time design validation success.
  • Played a key role in root cause analysis of product field failures, preventing recurrence by introducing design enhancements that reduced warranty claims by 64%.
  • Evaluated and implemented ISO-based design assurance frameworks, contributing to the successful release of QuickBooks in 2 global markets.
  • Facilitated regular cross-functional design review meetings ensuring issues were resolved before regulatory submissions, significantly reducing back-and-forths.
  • Streamlined design review schedules by implementing a more efficient digital tool, reducing schedule delays by 16 weeks per project.
  • Achieved a 15% increase in first-pass regulatory submission approvals by introducing robust implementation of design transfer best practices across teams.
  • Collaborated with quality engineering on failure investigations related to design, resulting in root causes being addressed 17 months earlier than projected.
  • Established metrics for continuous improvement of design processes, helping to improve overall design efficiency by 63% in 2022.
  • Standardized design assurance procedures across multiple product teams, reducing product launch delays caused by non-compliance issues by 83%.
  • Developed and conducted design assurance training programs for staff, improving team competency on FDA and ISO regulatory requirements by 28%.

Affiliations

  • Certified Medical Device Auditor (CMDA), ASQ, 2016-Present
  • Member, Product Safety Engineering Society (PSES), IEEE, 2018-Present
  • Associate Member, Biomedical Engineering Society (BMES), 2021-Present
  • Certified in Risk Management for Health Care Products, Risk Management Society (RIMS), 2022-2021
  • Member, International Society of Quality in Healthcare (ISQua), 2022-Present
  • Member, Society for Manufacturing Engineers (SME), 2015-Present
  • Certified Reliability Engineer (CRE), ASQ, 2019-Present
  • Graduate, Medical Device Product Development and Quality Assurance Program, Harbor & Co., 2018
  • Volunteer Instructor, framework Design Validation Bootcamp, 2023
  • Presenter, Design for Manufacturability Seminar, standard, 2022

Certifications

  • Advanced Root Cause Analysis Certification - HubSpot - 2023
  • Certified Risk Management Professional (CRMP) - 2020 - Summit Group
  • Certified Quality Engineer (CQE) - 2020
  • Cisco Certified Internetwork Expert (CCIE)
  • SAP Certified Application Associate
  • Certified Biomedical Auditor (CBA) - 2016
  • CompTIA Network+
  • Post-Market Surveillance Certification (PMS) - Northwind
  • ServSafe
  • Certified Medical Device Auditor (CMDA) - Northwind

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