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Quality/Validation Engineer

Company: Vantiva
Location: Camarillo
Posted on: November 21, 2022

Job Description:

Job Description

We're seeking an experienced Quality/Validation Engineer who wants to work with a highly interactive and dynamic team in our dedicated Microfluidics Innovation Center to provide support across engineering and operational activities to facilitate an environment of compliance and successfully meeting business objectives. - Are you looking to serve as a key member responsible for ensuring manufacturing and support activities meet requirements of 21CFR820, ISO 13485, and applicable In Vitro Diagnostic medical device regulations? Do you want to be part of a business venture who manufactures devices that could provide a life changing difference in the medical diagnostic field? - If so, join us for these exciting times!

Essential Functions of Position - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Primary responsibility is for Process and Equipment Validation activities

Supporting the inspection process throughout product realization, final product release activities, and ensuring Design History Record requirements are met

Primary responsibility for administering the Nonconformance (NCMR) program

Developing and leading Calibration and Maintenance programs for equipment, as applicable

Supporting responsibility for managing the Risk Management, Corrective and Preventive Action (CAPA), and Supplier Management program(s) meeting external and internal requirements

Supporting the authoring and revision of QMS documentation, preparing information for management reviews, participating in first-, second- and third-party audits as required

Lead improvement projects within the QMS through supportive tools, databases and project plans

Author, maintain, and present quality objectives through data exporting and metrics with professional presentations

Assisting in investigation of product quality and customer product complaints, identification of root cause, and implementation of correction and corrective actions

Assisting in the design and development of methods and tooling for the measurement, testing and inspection of products to support acceptance

Keywords: Vantiva, Camarillo , Quality/Validation Engineer, Other , Camarillo, California

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