Volt Information Sciences, Inc.
Volt has a great opportunity for a Quality Engineer to work in Fremont, CA with our client in the Biotechnology industry. Position Summary: This candidate will work closely with cross functional teams to write, edit, review and finalize technical documents to support design transfer activities.The individual will write or process, and implement all quality documents related to design transfer activities including procedure change orders and document change orders to reflect approved changes.Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented..Key Responsibilities: Write and provide guidance in Design Transfer documentationTechnically strong to work independently with R&D and various scientists to transfer information from technical transfer memorandum from an early Design Control phase into brand new work instructions.Designs a new layout for SOPs relating to Manufacturing production/process instructions, policies, and proceduresCreates part numbers and Bill of Materials into the Material Resource Planning (MRP) softwareLead cross functional documentation projects as requiredSupport Senior Scientists in corrective and preventive actions for technical issues to ensure timely and accurate documentation of root cause analysisClosely interacts and builds effective relationships with people across site to promote quality, consistency and complianceMinimum Requirements/Qualifications: BS/MS in a scientific discipline with 5-10 years diagnostic industry experienceFamiliarity with SAP/ ERP system.Familiarity with Design ControlMust be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).Knowledge of ISO 13485, FDA QSRs and GMPProofreading and editing skills, and an aptitude for numbers and detail oriented work requiring a high degree of accuracy.Proactive in suggesting improvements in workflow.Must have excellent customer service and listening skills.Able to sit, stand and/or use keyboard for long periods of time.Must have the skills to work as a strong contributor in a team effort.Demonstrate good flexibility with changes to working environment and deliver high quality results in a high-pressured deadline oriented environmentExperience in preparing manufacturing documents including SOPs, specification sheets and worksheets.Experience in IVD ManufacturingFamiliarity with Statistical Process Controls (SPC), Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma)Volt is an equal opportunity employer.
Volt Information Sciences, Inc.
Website : http://www.volt.com/
Volt Information Sciences, Inc. comprises complementary business units that offer customized talent, technology and consulting solutions to a diverse client base. Founded in 1950, Volt services worldwide industries including aerospace, automotive, banking & finance, consumer electronics, information technology, insurance, life sciences, manufacturing media & entertainment, pharmaceutical, software, telecommunications, transportation and utilities. Operating through an international network servicing North and South America, Europe and Asia, Volt is one of the world’s largest, most respected recruitment organizations. Volt delivers top talent in all skill categories as well as end-to-end workforce strategies, including managed services programs and recruitment process outsourcing. Large global enterprises rely on Volt for Vendor Management System (VMS) technology and e-procurement solutions to aid them in sourcing highly-skilled contingent workers and managing contingent labor spend.