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Senior Quality Affairs Manager

Company: HCL America Inc.
Location: Sunnyvale
Posted on: March 28, 2020

Job Description:

Lead andor support thorough investigations of customer complaints and quality issues (CAPAs, non-conformances, audit observations etc.) while ensuring effective corrective andor preventive actions. Function as the senior quality lead on New product development project teams as well as lifecycle management of current products, processes and associated materials in matters relating to Quality Engineering. Developing and implementing quality standards and quality control systems. Lead the development of comprehensive quality strategies Represent the Quality function on project teams, providing quality and regulatory compliance input, feedback, and guidance. Monitoring and analyzing quality performance. Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met. Collaborating with cross functional team to develop and implement controls and improvements. Ensuring that workflows, processes, and products comply with safety regulations. Investigating and troubleshooting product or production issues. Ensure completion of all corrective actions associated with the quality system and ensure that the CAPA process is in compliance with regulatory requirements. Developing corrective actions, solutions, and improvements. Ensure test methods used to verify product design or manufacture of productscomponents are appropriate and are properly validated. Reviewing codes, specifications, and processes. Proven track record on the follow quality skills like experience in Document Control, Internal Quality Audits, Corrective, Preventive Actions (CAPA), Complaint Handling, Supplier Management, Device History Record Review, Risk Management Activities, Quality Engineering, and Labeling General skills Commendable communication (verbalwritten) skills Good skills over the report preparation and presentation of the program output and team player Skills set Senior Quality resource, Quality Engineers and Managers, medical device industry exp. Mandatory Skills ISO 13485, MDR, ISO 14971

Keywords: HCL America Inc., Sunnyvale , Senior Quality Affairs Manager, IT / Software / Systems , Sunnyvale, California

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