Quality Engineer

Job Summary

Supporting the transition to IVDR, the temporary Quality Engineer will facilitate risk management assessments, update legacy product risk files, and coordinate with cross-functional teams while working remotely.

Key responsibilities:

• Facilitate risk management assessments and update risk plans and reports in accordance with company procedures
• Coordinate meetings with stakeholders to ensure completeness and accuracy of risk profiles and identify new risks
• Support the migration of product risk management files into the eQMS system and assess legacy documentation for compliance with IVDR requirements

Required qualifications:

• Bachelor's degree or equivalent in a related technical or engineering discipline
• 2-3 years of experience in quality engineering and risk management
• General knowledge of Medical Device/GMP/ISO regulations, including ISO 14971 and ISO 13485
• Understanding of risk management principles and regulations
• Proficiency in Microsoft Office and familiarity with SAP, EtQ, and/or Veeva is a plus