Quality Engineer

• Facilitate risk management assessments, including updates to risk management plans and reports
• Consolidate and update product system hazard analysis files in accordance with company procedures and applicable standards
• Coordinate and lead cross-functional meetings to gather required data and ensure completeness and accuracy of risk profiles
• Identify existing hazards, assess new risks, and escalate issues requiring additional input or mitigation to management
• Support migration of product risk management files into the eQMS, ensuring accurate metadata and proper linkage to legacy DHF binders
• Review legacy risk documentation to identify gaps against IVDR transitional activities, new guidance, and updated global risk management procedures
• Support additional IVDR-related technical documentation updates, gap assessments, and eQMS migrations as needed
• Operate effectively in a dynamic, fast-changing environment while supporting cross-functional teams with shifting priorities
• Demonstrate ownership, accountability, and the ability to work independently with minimal oversight

• Bachelor's degree (or equivalent) in an engineering or related technical discipline
• 2–3 years of experience in quality engineering, risk management, or a related field (or equivalent combination of education and experience)
• Working knowledge of quality engineering principles and risk management methodologies
• Understanding of medical device regulations and quality systems, including ISO 14971, ISO 13485, MDSAP, and FDA CFR Part 820 (CFR 210/211 preferred)
• General understanding of risk management regulations, principles, and practical application
• Strong critical thinking, problem-solving, communication, coordination, and teamwork skills
• Proficiency with Microsoft Office and Visio

Experience with SAP, EtQ, and/or Veeva is a plus