Quality Engineer

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

Are you and experienced quality engineer who would like to work for a global supplier of medical devices that is just over an hour outside of Dallas TX and offers very competitive salary, benefits, bonus and relocation assistance if required. This position will be responsible for the quality process including critical process characteristics, standards, audits, complaint resolutions, training and laboratory functions related to FDA 21 CFR 820, FSSC22000, and ISO 13485:2016.

Responsibilities

• Ensure integration of quality systems to ensure a common quality system throughout the facility and share best practices across the North American plant locations.
• Provide manufacturing personnel with quality systems and tools to allow effective evaluation of products and processes.
• Ensure the application of advanced quality tools to provide process improvement to the manufacturing group.
• Ensure the quality management system meets the company’s medical device expectations and goals.
• Formulate and maintain accurate documentation to meet all quality system and medical device expectations.
• Lead and manage direct and indirect reports within the facility to meet or exceed targets for the medical device quality management system.
• Maintain all aspects of the ISO 8 cleanroom including system validation and ongoing environmental monitoring.
• Proactively review and improve quality systems and processes.
• Investigate moderately complex manufacturing product quality and compliance issues (e.g. CAPA, non-conformances, audit observations) in design and production processes prior to final product customer release. Make recommendations and confirm results.
• Assist in the development and initiate standards and methods for inspection, testing, and evaluation, utilizing quality engineering analytical tools. Formulate quality assurance policies and procedures.

Document Control Responsibilities

• Provides support to the manufacturing organization to ensure that Document Control is audit ready (internally and/or externally).
• Maintains document control systems, ensuring accuracy, organization, accessibility, and compliance with applicable standards.
• Manages Manufacturing MRP data and related databases, ensuring data accuracy, integrity, and timely updates.

This high-visibility position will report directly to the Quality Manager and will present the opportunity to work closely with manufacturing, customer service and other quality professionals to problem-solve and support new and existing projects.

Qualifications

• Bachelor’s degree required; preferable in an appropriate technical discipline (Engineering,Math,Science).
• At least two years related experience; medical device experience highly preferred.
• At least two years’ experience with plastic molding equipment and rotating machinery highly preferred.