Quality Engineer II
S
Spectrum Plastics Group
📍 Tucson, Arizona, United States
Job Description
Job Purpose:
Support and maintain compliance of the medical device Quality Management System (QMS), strategic quality initiatives, and cross-functional quality projects.
Drive continuous improvement in product quality, regulatory compliance, and risk management across the product lifecycle.
Maintain a strong working knowledge of core QMS elements, applicable standards, customer requirements, and global regulatory expectations.
Essential Duties and Responsibilities:
* Assist or lead large-scale or cross-functional quality projects involving product lifecycle management, validation, CAPA, audit readiness, risk management, or supplier quality improvement.
* Serve as the Quality lead for assigned customer accounts and product groups, including support for customer complaints, nonconformances, CAPAs, customer communications, external audits, and related quality activities.
* Responsible for supporting sterilization and enviro...
Support and maintain compliance of the medical device Quality Management System (QMS), strategic quality initiatives, and cross-functional quality projects.
Drive continuous improvement in product quality, regulatory compliance, and risk management across the product lifecycle.
Maintain a strong working knowledge of core QMS elements, applicable standards, customer requirements, and global regulatory expectations.
Essential Duties and Responsibilities:
* Assist or lead large-scale or cross-functional quality projects involving product lifecycle management, validation, CAPA, audit readiness, risk management, or supplier quality improvement.
* Serve as the Quality lead for assigned customer accounts and product groups, including support for customer complaints, nonconformances, CAPAs, customer communications, external audits, and related quality activities.
* Responsible for supporting sterilization and enviro...