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Sr. Quality Engineer

Company: Cannon Quality Group, LLC (CQG)
Location: Redwood City
Posted on: May 3, 2021

Job Description:

As Sr. Quality Engineer Team Member, you will be in charge of client-facing engineering solution development and implementation. Responsibilities range from:Participate as Sr. QE in client-facing projectsCollect and define project requirements and develop solutionsAdvise clients on QE concepts, principles, and practices related to the companies solutions and products.Support Design Control, Risk Management EffortsAbility to Support Software Development efforts a plusLeverage the internal team to maximize efficiency on projectsWork closely with Operations to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-Proofing, etc.)Review/approve manufacturing and inspection tool design and related system documentationReview/approve product and process change control documentation and specifications.Participate in the development, review, and approval of process and equipment validation/qualifications (IQ, OQ & PQ)Work with manufacturing to develop process control and manufacturing metrics.Continual assessment of current client systems and making appropriate recommendations for change, taking into considering the client's goals, business stage, and the budgetThe role includes informing the client of the risks associated with any decisions they intend to make with respect to their quality system and work with the risk that the client is willing to assume in the deployment of their system.Participate in internal and client-facing projects from the initial requirements phases through to the QA and deployment phasesConduct or assist with complaint handling, including device failure investigation, documentation, file review, and reportability evaluationHelp develop methodologies from existing ideas and develop new ideas based on experience and contact with the client and prospect base. Additional Responsibilities include but are not limited to:Design AssuranceEnsure design controls in product development and improvement project activities, including risk management, design reviews, tagging/tracking, non-product tools validation, and product/process validationAuthor and/or review design input/output/verification/validation documents as appropriateAuthor and/or review documents for 510(k)sWork with R&D on Technical File for CE MarkingWork with R&D on EMC and safety (UL/CSA) certificationAudit DHFManufacturing QAReview activities for receiving inspection, device history records, component release, and process validationReview and approve DMR, DHR, and Validation Protocols and Reports related to processes, equipment, facility, and computer systemsInterface with Operations to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation, and trainingManage the equipment calibration programSterilization and Biocompatibility QAEstablish, monitor, and maintain EO sterilization programConduct product biocompatibility testingCEREstablish, monitor, and maintain CER programEDUCATION:Bachelor's Degree in engineering/scientific discipline CQE, RAC, RAB, or other quality and regulatory certificates are beneficial EXPERIENCE REQUIREMENTS:5+ years of in-depth Quality System Implementation in compliance with FDB, FDA, and ISO 13485Experience with the R&D lifecycle with emphasis on the QE aspectsKnowledge of statistics and application of statistical methodsExperience in a medical device company is desirable. Understanding of US FDA Quality System Requirements, ISO/EN 13485:2003, and MDD requirements is desirableAdditional Qualifications:Quick to learnPositive, results-oriented, and energetic team playerExcellent analytical and problem-solving skillsExcellent interpersonal and communication skillsAbility to work independently and collaborativelyAbility to prioritize and manage to critical project timelines in a fast-paced environment; must be able to handle multiple responsibilities concurrentlyMust be organized, have an eye for detail, and be able to put ideas into a tangible formA logical and organized thought patternAbility to follow established policies and procedures and comply with regulatory requirementsAbility to deal with unresolved situations, frequent changes, delays, or unexpected eventsAbility to point out issues so that they are appropriately addressed**no relocation reimbursement**All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin

Keywords: Cannon Quality Group, LLC (CQG), Redwood City , Sr. Quality Engineer, Other , Redwood City, California

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