Opportunity Description
Description: Staff Quality Engineer- Pharma and Diagnostics
Job Summary
This role ensures that *** IVD products meet stringent regulatory requirements and quality standards. The Staff Quality Engineer will lead quality engineering initiatives, support product development and manufacturing processes, and drive continuous improvement in the quality management system.
Key Responsibilities
" Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations, as appropriate, for IVD products
" Conduct hazard analysis and risk assessments for IVD products according to ISO14971 throughout the IVD product lifecycle
" Lead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirements
" Oversee corrective and prevent...
Job Summary
This role ensures that *** IVD products meet stringent regulatory requirements and quality standards. The Staff Quality Engineer will lead quality engineering initiatives, support product development and manufacturing processes, and drive continuous improvement in the quality management system.
Key Responsibilities
" Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations, as appropriate, for IVD products
" Conduct hazard analysis and risk assessments for IVD products according to ISO14971 throughout the IVD product lifecycle
" Lead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirements
" Oversee corrective and prevent...
Ready to Apply?
Submit your application for Staff Design Quality Engineer, Design Quality at Integrated Resources, Inc
Apply for this Position