Quality Assurance Engineer

Daniel Sisson Greenwood, IN 317-***-**** ******.******@****.***

Professional Summary

Results-driven Quality Engineer & Web Developer with a decade of experience in medical device manufacturing, quality assurance, and process optimization. Recently trained in full-stack development through Columbia University's intensive coding bootcamp. Adept at integrating software solutions to enhance manufacturing efficiency and quality control. Passionate about developing scalable, user-friendly applications and optimizing technical workflows. Technical Skills

Software Development: JavaScript, React, Node.js, TypeScript, SQL, GraphQL, Cypress, Python, MERN Stack

Engineering & Quality Assurance: Process Validation, Design Control, Risk Assessment, Quality Management Systems, Manufacturing Process Optimization Education

Columbia University Software Development Coding Bootcamp Dec 2024 – June 2025 Purdue University Bachelor of Science in Biomedical Engineering Aug 2009 – May 2013 Professional Experience

Helmer Scientific Quality Engineer Jan 2024 – Present

• Conducted studies to identify and implement optimal manufacturing processes.

• Developed software solutions to track and analyze quality metrics. Cooper Surgical (Short-Term Contract) Quality Assurance Specialist May – Nov 2023

• Created Design Control and Risk Assessment documentation, including DIOVV and FMEA.

• Designed and coordinated Design Verification Testing for transit testing.

• Developed manufacturing and quality specifications for new product lines. Beckman Coulter Quality Assurance Engineer Apr 2017 – Apr 2023

• Led process capability investigations and implemented process improvements.

• Audited quality systems to ensure compliance with regulatory standards.

• Spearheaded the launch of a new Quality Management System software environment. CRI Medical Development Engineer May 2015 – Feb 2017

• Managed contract manufacturing projects for startups and Fortune 500 companies.

• Led development engineering efforts for Class II and Class III medical devices.

• Conducted design verification, validation, and process optimization activities. Zimmer-Biomet (Short-Term Contract) Development Engineer Jan 2014 – May 2015

• Ensured compliance of existing Total Knee Replacement and Revision products with regulatory requirements.

• Developed and remediated Design History Files (DHFs) to align with FDA and ISO standards.

• Created, reviewed, and revised Design Control documentation, including Traceability Matrices and FMEAs.

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