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Quality Engineer
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Senior Quality Engineer
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Quality Engineer II
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Senior Quality Engineer
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Sr. Quality Engineer
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Senior Quality Engineer
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Senior Quality Engineer
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10X Genomics Pleasanton, United States Freelance10x Genomics is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization. In this role, you will leverage your engineering skills and make meaningful contributions toward the the development of cutting edge-instruments that enable scientific disc ...
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Senior Quality Engineer
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10X Genomics Pleasanton, United States10x Genomics is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization. In this role, you will leverage your engineering skills and make meaningful contributions toward the the development of cutting edge-instruments that enable scientific disc ...
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Senior Quality Engineer
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10X Genomics Pleasanton, United States10x is seeking a · Senior Quality Engineer, · who will be a member of the · Global Quality organization , reporting to the Senior Director of Global Quality and Document Control. In this cross functional quality role, you will be responsible for identifying, documenting, analy ...
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Engineer II, Quality
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Engineer II, Quality
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Senior Quality Engineer
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Quality Assurance Engineer
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Quality Engineer III
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Clinch Pleasanton, United StatesBe part of the digital biology revolution... · Bio-Rad is a leader in the development of innovative droplet digital PCR systems. Bio-Rad's QX200 ddPCR system represents a new era in reliability and affordability across a range of applications for life science researchers and mol ...
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Quality Engineer
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Quality Engineer
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Quality Engineer
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BioSpace, Inc. Dublin, United StatesJob Details · Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key t ...
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Quality Engineer
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Quality Engineer - Pleasanton, United States - Katalyst Healthcares and Life Sciences
Description
Responsibilities:
Participate in design reviews, Risk Management, Validation & Verification plans and reports during Product Development as required. Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufacturing process readiness.
Support and/or drive Equipment and Process Validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (OQ), internally or externally.
Development of Master Validation Plan, Quality Plans and Reports Provide quality inputs and/or requirements as applicable. Focuses and determines proper engineering principles on reliability issues.Drive and own quality assurance and requirements during development phases and post-market release, including Change Control Implement lessons learned in other/new products, respectively new or running projects.
Identify and manage Critical to Quality (CTQ's) Adhere to defined and communicated Corporate Quality requirements, applicable Regulatory Standards, methods, and procedures, with openness to identifying improvements.
Focus on streamlining activities for increased efficiencies.Control of Documentations Requirements:
Bachelor's degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred.
Demonstrated competency with desired 8+ years of quality engineering and/or operations experience including a minimum 5 years' experience in an electro-mechanical, assembly and test manufacturing environment.
Proficiency in reading and interpreting mechanical drawings and GD&T. Medical Device Auditor certification preferred.Certified Six Sigma Black Belt, Green Belt or Lean Master preferred with proven completion of projects in which solutions were sought at the root level of the problem.
Supplier Development and Management experience.Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO 13485, ISO 14971, and all other international regulatory requirements with which client complies.
Design Control and/or Design Assurance experience Excellent analytical skills. Experience working in cross-functional, cross-business and cross-cultural projects. Hands-on personality. Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook. 10% Travel