Quality Engineer - Medical Devices

Full-time Other-General

Quality Engineer - Medical Devices QMS Knowledge of Regulatory standards CFR820 , ISO 13485 & 14971, 60601 Hands on experience on Risk Management. Good understanding of Post Market Survey and complaint handling. Design plan Medical Process DQC Deviation and CAPA preferred. • Be a part of core project team and support the quality engineering across the entire development cycle • Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects. • Lead the development and implementation of design verification and validation plans with project design lead. • Lead the development of Critical to Quality (CTQs), design input and output documents. • Lead the fixture qualification and test method validation. • Participate and implement tools like Design of Experiments (DOE’s), FMEA sessions, Risk Management and ensure compliance to CTQ’s and safety requirements. • Manage electronic document control and version control on a...