– Min 4-5 yrs quality engineering experience, hands on experience on EU MDR, New product development experience is must
– Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements.
– Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards.
– Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
– Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.