Location
Dallas, TX, United States
Posted
July 25, 2026
Job Description
The Quality Engineer I will be responsible for supporting and improving Quality Management System (QMS) processes to ensure compliance with FDA, ISO, customer, and company requirements within a Contract Development and Manufacturing Organization (CDMO) environment. This position partners with Manufacturing, Operations, Validation, Regulatory Affairs, Supply Chain, R&D, and customers to drive quality initiatives, investigate nonconformances, execute CAPAs, support audits, and improve manufacturing processes for medical device, pharmaceutical, biologic, or combination products.
Duties are as follow:
+ Maintain compliance with FDA Quality System Regulation, cGMP requirements, ISO 13485, ISO 9001, and applicable customer requirements.
+ Support and execute Quality Management System activities including CAPA, nonconformance management, change control, risk management, deviation investigations, and complaint trending.
+ Review and approve quality records to ensu...
Duties are as follow:
+ Maintain compliance with FDA Quality System Regulation, cGMP requirements, ISO 13485, ISO 9001, and applicable customer requirements.
+ Support and execute Quality Management System activities including CAPA, nonconformance management, change control, risk management, deviation investigations, and complaint trending.
+ Review and approve quality records to ensu...