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Engineering & Quality Assurance Supervisor
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Quality Engineer
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Quality Engineer
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Manager - Quality and Engineering
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Senior Quality Engineer
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Principal Quality Engineer
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BioTalent Laguna Hills, United StatesThe primary responsibility of the quality engineer is to maintain, and support compliance activities associated with product manufacturing, non-conformance reports (MRB), customer complaints, product acceptance and release through active involvement & presence in the assembly ope ...
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Principal Quality Engineer
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BioTalent Laguna Woods, United StatesThe primary responsibility of the quality engineer is to maintain, and support compliance activities associated with product manufacturing, non-conformance reports (MRB), customer complaints, product acceptance and release through active involvement & presence in the assembly ope ...
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Staff Quality Engineer
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Engineer Staff, Quality
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Engineer Staff, Quality
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Engineer Staff, Quality
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Engineer Staff, Quality
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MicroVention Aliso Viejo, United StatesProduction Support FocusLead quality engineering projects to support the manufacturing of medical devices. Work with Manufacturing and R&D in leading efforts to resolve product quality issues. Support manufacturing process changes and product design improvements.Product Developme ...
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Staff Quality Engineer
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MicroVention-Terumo Aliso Viejo, United StatesWorking for a company voted Great Places to Work - 2022, the Staff Engineer, Quality (New Products) works with R&D and Manufacturing to lead design control activities for the development and manufacture of medical devices and resolve product quality issues. · What You'll Be Doin ...
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Staff Engineer, Quality
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Supplier Quality Engineer
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Staff Quality Engineer
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MicroVention-Terumo Aliso Viejo, United StatesWorking for a company voted Great Places to Work - 2022, the Staff Engineer, Quality (New Products) works with R&D and Manufacturing to lead design control activities for the development and manufacture of medical devices and resolve product quality issues. · Do not wait to appl ...
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Quality Specialist/ Engineer
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Customer Quality Engineer
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Supplier Quality Engineer
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Quality Engineer
6 days ago
TalentBurst, an Inc 5000 company Irvine, United StatesPosition: Quality Engineer I/II · Location: Irvine, CA (100% onsite) · Duration: 3 Months Contract · Job Description: · This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering ...
Principal Quality Engineer - Laguna Woods, United States - BioTalent
Description
The primary responsibility of the quality engineer is to maintain, and support compliance activities associated with product manufacturing, non-conformance reports (MRB), customer complaints, product acceptance and release through active involvement & presence in the assembly operations.
Duties and Responsibilities:
Daily support of production requirements and issues through active involvement & presence in the assembly operations and clean rooms.
Maintain and support compliance activities associated with the Quality Management System (QMS) to comply with international and domestic regulations.
Maintain the CAPA system and files. Coordinate CAPA activities including investigations, root cause analysis, and implementation of corrective actions with effectivity analysis.
Develop quality assurance specifications, test devices & methods, inspection procedures, sampling plans and related written procedures.
Support new product launch, Risk Management Activities (FMECA), Master validation plans, product V&V, Process Validations, and Design Transfer into manufacturing.
Implement and review changes to existing products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
Manage the Supplier Evaluation and Qualification process. Work with purchasing to manage the qualification process of new suppliers and re-evaluation of existing suppliers.
Support & develop quality metrics and monitor production/product non-conformance trends in order to alert senior management of these trends so corrective actions can be implemented.
Provide quality engineering support to quality control and provide guidelines on inspection methods and equipment used including measuring systems capabilities.
Work with Manufacturing and Engineering teams to coordinate pilot production of new process validations and risk analysis activities.
JOB QUALIFICATION REQUIREMENTS
Bachelor's degree (B.S.) & Five (5) years minimum experience in quality engineering and quality assurance.
Current knowledge of FDA Quality System Regulations and Guidelines, ISO 13485, and standards applicable to company products.
Knowledge and understanding of Quality and Regulatory concepts and application
Strong analytical, planning and organizational skills
Strong interpersonal and communications skills (oral & written)
Self-starter with ability to work independently under pressure and react quickly to changing priorities
Proficient in MS Office products.
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