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Quality Assurance Engineer

Company: Ust
Location: Gainesville
Posted on: January 16, 2022

Job Description:

Maintains and enforces a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes. Performs regulatory surveillance (FDA, EU, UL, IEC, etc) gap closure activities. Internal and external audit support as well as support of key QA processes (CAPA, complaints, auditing, QMS reviews, management review, metrics gathering and operations projects). Facilitates the transition/ deployment of the PQMS, and coordinate its deployment. Assists with oversight of QMS- assure policies, procedures and instructions in place to support ISO-9001, ISO-14001, PED/ASME and Corporate Requirements, (ie: ISO-13485) working with local document control team and functional Leaders (who share QMS ownership responsibility). Maintains close integration with site leaders and facility partners to drive continuous improvement activities. Participates in procedure updates, assuring new items and updates are incorporated in the local QMS in a timely manner and assisting with the formal assessment of changes for local QMS changes. Assists with external audits (PH, ISO, EHS), audit responses and timely resolution. Supports Business Partners with problem solving tools & data to drive continuous improvement, Engage with global partners to share best practices, development, and monitoring and driving improvement of key metrics, participation in the budgeting and planning processes. Assist with other activities as Jobble

Keywords: Ust, Gainesville , Quality Assurance Engineer, Engineering , Gainesville, Florida

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