Kanny Huang
Greenwood,IN
Summary
Quality Engineer with a strong foundation in quality management systems including ISO 13485 and IATF 16949. Expertise in measurement system analysis and root cause analysis investigations, alongside a collaborative approach to addressing quality challenges, driving efficiency, and ensuring compliance in a regulated environment.
Overview
4
4
years of professional experience
Work History
Quality Engineer
Marian, Inc.
Indianapolis, Indiana
07.2024 - Current
- Led investigations of customer complaints, internal quality events, and nonconforming material using structured root cause analysis methodologies.
- Analyzed quality metrics and manufacturing data to identify trends and drive continuous improvement
- Collaborated with cross-functional teams to resolve quality issues, enhancing product reliability and customer satisfaction.
- Supported quality engineering for manufacturing operations and new product launches, ensuring alignment with quality standards.
- Performed Measurement System Analysis (MSA) studies, including Gage R&R evaluations.
- Assisted in training team members on quality assurance protocols and best practices.
Quality Engineer
Avalign Delivery Systems
Greenwood , IN
05.2023 - 04.2024
- Provided quality engineering support in a regulated medical device manufacturing environment.
- Ensured compliance with FDA regulations and ISO 13485 requirements.
- Supported customer quality documentation and nonconformance investigations.
Engineering Intern
Cook Polymer Technology
Bloomington, Indiana
06.2022 - 08.2022
- Conducted supplier CAPA investigations and quality inspections to ensure compliance with quality standards.
Education
Bachelor of Science - Biomedical Engineering
Trine University
Angola, IN05-2023
Skills
- IATF 16949 and ISO standards
- APQP and control plans
- Measurement system analysis
- Statistical process control
- Nonconformance management
- Internal and customer audits
- Supplier quality assurance
- 8D problem solving
- Root cause analysis
- AutoCAD proficiency
Timeline
Quality Engineer
Marian, Inc.
07.2024 - Current
Quality Engineer
Avalign Delivery Systems
05.2023 - 04.2024
Engineering Intern
Cook Polymer Technology
06.2022 - 08.2022
Bachelor of Science - Biomedical Engineering
Trine University