The Quality Engineer will collaborate cross-functionally to resolve quality issues, drive continuous improvement, and ensure adherence to the Quality Management System and regulatory standards
Job Summary
The Quality Engineer will collaborate cross-functionally to resolve quality issues, drive continuous improvement, and ensure adherence to the Quality Management System and regulatory standards.
Escalate quality issues to QA and/or Engineering Management and support timely resolution.
Apply statistical and risk management tools (e.g., FMEA) to support decision-making and continuous improvement.
Matching Summary
The Quality Engineer will collaborate cross-functionally to resolve quality issues, drive continuous improvement, and ensure adherence to the Quality Management System and regulatory standards.
Skills & Requirements
Must-have
resolve quality issues
continuous improvement
regulatory standards adherence
investigations of non-conformances
risk assessments and CAPA
containment of non-conforming product
quality data analysis and trending
audit support
Nice-to-have
cross-functional collaboration
customer trust and market access
reputation maintenance
Key Requirements
Bachelor’s degree in Engineering or related technical field
3 or 5 years of experience in Quality Engineering
Strong working knowledge of 21 CFR 820, ISO 13485, and MDSAP