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Staff Quality Engineer

Company: ThermoFisher
Location: Fremont
Posted on: May 3, 2021

Job Description:

KeyResponsibilities:Develop and/or implement supplier quality processes in a medical design/manufacturing environment for new product introductions and sustaining operations.Use statistical and risk management techniques for assessing supplier performance (for selection, qualification and monitoring).Establish and participate in supplier qualification/development activities to ensure that products meet design and manufacturing requirements as part of Design Transfer.Advise and evaluate supplier selection, qualification and monitoring activities.Serve as Core or extended core team member on New Product Development projects representing supplier quality, to ensure compliance with design controls per ISO 13485 and FDA QSR. Participate in design and post-launch reviews, as necessary.Evaluate and implement protocols and methods (including SOPs) to ensure that incoming material and manufactured products are compliant with internal requirements as well as to standards/regulations for worldwide distribution.Perform analysis of supplier performance data to identify trends and recommend updates or changes to quality standards and procedures when necessary.Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement.Lead cross-functional teams in the execution and reporting of supplier quality / purchasing improvement projects with a focus on overall process improvements, scrap reduction and supplier quality improvement.Active participation and support of the internal and supplier audit processes. Participate, as supplier quality subject matter expert, in audits conducted onsite or virtually.Drive corrective, preventive, and closure actions for project issues related to quality and/or test non-conformance.Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.Able to establish, monitor and maintain quality and distributor agreements and/or statements of work, with customers, suppliers, and other Thermo Fisher sites, as applicable.Maintain and support the selection, qualification and maintenance of supplier files and site approved supplier list (ASL).Support supply chain operations to ensure that products and processes comply with the relevant requirements of the quality and environmental health and safety management system.Analyze supplier nonconformance trends to select improvement priorities and evaluate the effectiveness of corrective actions.Conduct supplier audits including product inspections, in person and / or virtually. Determine, execute proper supplier corrective actions. Validate their effectiveness and efficiency.Respond to supplier quality issues and actions to requests from Design, Service, Sales, and Customers.Assist site team in establishing, implementing, and maintaining standard operating and quality procedures.Lead supplier or OEM improvement projects using effective project management skills.Minimum Qualification/Requirements:Bachelor's degree in Engineering (Chemical Engineering, Chemistry, Biochemistry).Minimum 5 to 8 years of related experience in Medical Device / Biologics/ IVD manufacturing.Considerable hands-on experience in Medical Device and/or In Vitro device manufacturing with strong working knowledge of FDA QSR, IVDD and ISO 13485JobSummaryJob number: 155536BRDate posted : 2021-04-06Profession: EngineeringEmployment type: Full-TimeSDL2017

Keywords: ThermoFisher, Fremont , Staff Quality Engineer, Other , Fremont, California

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