MDR - Quality Engineer II - Exempt

Role Summary

The Quality Engineer (QE) supports MDR remediation activities and ongoing manufacturing quality assurance for designated product families at the Dexter site. The role focuses on ensuring manufacturing processes, labeling, packaging, and documentation comply with internal quality standards and regulatory requirements. The QE collaborates closely with manufacturing, planning, warehouse operations, and product engineering to assess risks, implement process controls, and support product and process changes required for MDR compliance.

• Conduct First Article Inspections (FAIs) and complete associated documentation and reports.


• Develop and maintain risk management documents (pFMEAs) and Control Plans for product families and technical files.


• Conduct production floor observations and process tours to ensure risk assessments reflect current manufacturing practices....