Job Details

This position is responsible for supporting electrode product and process sustaining activities through the application of Quality engineering skills for medical devices. Focuses on process, equipment, and design verification and validations; working with teams to develop manufacturing and quality processes and define their related tools; troubleshooting and support of manufacturing floor and field issues, and review and approve validations. Essential Job Functions: - Review and approve verification and validation protocols and reports - Participate in Change Control review and approval activities as required - Provide technical guidance and oversight to Quality Engineers - Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971 - Develop and implement quality plans - Ensures post market surveillance reviews are conducted and reports documented according to schedule - Participate in CAPA efforts, and...Quality Assurance Engineer, Quality Assurance, Quality Engineer, Assurance, Engineer, Senior, Technology