Senior Quality Engineer Professional
This role is an opportunity to lead digital quality initiatives and support the integration of automated, data-driven processes across manufacturing and quality systems.
The ideal candidate will have a strong understanding of FDA, ISO 13485, and EU MDR standards, as well as experience with digital quality systems, MES, and ERP.
Key Responsibilities:
* Maintain and improve the Quality Management System (QMS) in alignment with regulatory requirements.
* Support the implementation of digital transformation initiatives by integrating quality controls into automated and data-driven manufacturing processes.
* Ensure compliance with applicable regulations.
* Collaborate with cross-functional teams to embed quality assurance into digital workflows, MES, and ERP Systems.
* Monitor and validate data integrity across digital platforms used in production and quality control.
Requirements:
* Bachelor's degree in Engineering, Quality, or a related field.
* 5+ years of experience in quality engineering within a regulated manufacturing environment.
* Strong knowledge of FDA, ISO 13485, and EU MDR standards.
* Experience with digital quality systems, including MES and ERP.
* Experience in management or routers/Bill of Materials (BOMs) and associate milestones in manufacturing paperwork/translation to a digital platform is advantageous.
* Experience in DHR/DMR management/collation through use of electronic systems and MES is also beneficial.
* Audit and presentation skills are advantageous.