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Job #03268

About our client Our client is the world's leading OEM supplier of medical supplies and devices. Position Location Senior Quality Engineer Northern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform professional quality engineering assignments with a high degree of complexity with a wide latitude for independent action and decision 2) Apply complex engineering principles to develop methods and procedures to improve/maintain product and process quality standards 3) Prepare plans, specifications and cost estimates 4) Perform internal audits to GSR and ISO requirements including audit planning, execution, reporting and auditor training 5) Act as a key liaison with regulatory auditors (UL, CSA and FDA) 6) Facilitate submission of safety packages to UL/CSA as requested 7) Maintain required documentation and coordinate UL/EMC CE testing of new products as well as maintain certification for older products 8) Dispose defective material (MRB) 9) Maintain CAPA procedure, training personnel in CAPA and root cause analysis, guiding personnel through CAR processing, evaluating effectiveness of CAPA process and initiating action (as required) to improve effectiveness 10) Implement supplier evaluations, audits, performance monitoring, scoring, ranking, performance improvement actions and corrective action requests 11) Serve on Material Review Board and process vendor returns 12) Support receiving inspection operation by specifying, acquiring and/or developing tools/equipment, procedures/techniques as well as by resolving issues 13) Monitor actions taken in response to customer communications to ensure they are appropriately handled 14) Develop, modify and maintain procedures/processes for hardware and software quality assurance and supplier quality assurance activities 15) Design or specify inspection and testing mechanisms as well as equipment required to conduct quality assurance tests 16) Develop, modify, apply and maintain quality standards for process and product development into partially finished or finished product 17) Contribute regularly to developing new concepts, techniques and standards 18) Interact with senior internal/external personnel on significant matters often requiring coordination between organizations 19) Understand completely and apply principles, concepts, practices and standards with a full and competent knowledge of industry and company practices, specifically FDA QSR/ISO 9001 Requirements 1) BA (4 year) preferred with RAPS certification, CQE, CQA a plus 2) 9 years of related professional experience 3) 5 – 6 years of experience in supporting product development 4) Experience in medical device manufacturing 5) Supervisory or managerial experience a plus 6) Excellent communication skills (written and verbal) 7) Superb interpersonal-relationship, facilitation and presentation skills 8) Excellent IT (MS Office and Visio tools) and decision-making (based on logic and realization of customer value) skills 9) Self-starter with ability to work with little to no supervision 10) Ability to work effectively in culturally diverse situations and communicate effectively at varying technical levels with an international audience 11) Ability to understand process engineering 12) Willingness to travel internationally (occasionally)