Medical Device Quality Engineer | ISO 13485, FDA, Relocation

HotRun Inc.; Longview (TX); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Relocation assistance

Bonus

Competitive benefits

Job summary

HotRun Inc. is seeking an experienced Quality Engineer to support a global medical devices supplier near Dallas, TX.

The role focuses on quality processes, audits, CAPA, training, and laboratory functions in line with FDA 21 CFR 820, FSSC22000, and ISO 13485:2016. Responsibilities include integrating quality systems across North American plants, enabling quality tools for manufacturing evaluation, and maintaining ISO 8 cleanroom operations.

Qualifications

• Bachelor's degree in engineering, math, or science.
• 2+ years of related experience; medical device experience preferred.
• Experience with plastic molding equipment and rotating machinery preferred.

Responsibilities

• Ensure quality systems are integrated across the facility for a unified QA approach.
• Provide QA tools to manufacturing for product/process evaluation.
• Apply advanced quality tools for process improvement in manufacturing.
• Maintain ISO 8 cleanroom and perform system validation and monitoring.
• Lead and manage QA staff to meet ISO 13485 expectations and goals.
• Investigate CAPA, non-conformances, and audit observations pre-release.
• Develop and implement inspection, testing, and evaluation standards.

Skills

Quality systems

CAPA

Audits

ISO 13485

FDA 21 CFR 820

Education

Bachelor's degree in Engineering/Science

Tools

Document control software

Job description

HotRun Inc. is seeking an experienced Quality Engineer to support a global medical devices supplier near Dallas, TX.

The role focuses on quality processes, audits, CAPA, training, and laboratory functions in line with FDA 21 CFR 820, FSSC22000, and ISO 13485:2016. Responsibilities include integrating quality systems across North American plants, enabling quality tools for manufacturing evaluation, and maintaining ISO 8 cleanroom operations.