Quality Engineer

HotRun•Longview, TX

7d•Onsite

About The Position

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. The role ensures integration of quality systems to ensure a common quality system throughout the facility and shares best practices across North American plant locations. It provides manufacturing personnel with quality systems and tools for effective evaluation of products and processes, and ensures the application of advanced quality tools for process improvement. The Quality Engineer ensures the quality management system meets the company’s medical device expectations and goals, formulates and maintains accurate documentation, and leads and manages direct and indirect reports to meet or exceed targets for the medical device quality management system. This role also maintains all aspects of the ISO 8 cleanroom, including system validation and ongoing environmental monitoring. It proactively reviews and improves quality systems and processes, and investigates 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, making recommendations and confirming results. The position assists in the development and initiation of standards and methods for inspection, testing, and evaluation, utilizing quality engineering analytical tools, and formulates quality assurance policies and procedures. It provides support to the manufacturing organization to ensure Document Control is audit ready and maintains document control systems, ensuring accuracy, organization, accessibility, and compliance with applicable standards. The role also manages Manufacturing MRP data and related databases, ensuring data accuracy, integrity, and timely updates. This high-visibility position reports directly to the Quality Manager and presents the opportunity to work closely with manufacturing, customer service, and other quality professionals to problem-solve and support new and existing projects.

Requirements

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

Nice To Haves

medical device experience highly preferred
plastic molding equipment and rotating machinery highly preferred

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.
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.