The Post-Market Quality Engineer (QE) will provide technical quality leadership and support for on-market medical device and combination products. This Post-Market QE will: Work collaboratively with internal Quality and cross-functional colleagues to ensure medical devices and combination products comply with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI), specifically supporting: - Transition ISO 13485 certification and product licenses between locations / entities due to pending closure of Westlake Village facility - Establishment of harmonized processes to meet new ISO 13485 and MDR requirements expected to be implemented in 2018 - Internal / external inspections and notified body interactions related to transition and new regulations - Supplier quality related activities during transition of responsibilities from SQM to Device Quality
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