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Quality Engineer
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Quality Engineer
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Hyve Solutions Fremont, United States@HYVE Solutions, missions to help customers, business partners, and employees achieve success through shared goals, strategies, resources and technology solutions. · Salary range: $100 - $110K · Quality Engineer · Hyve Solutions Corporation designs and delivers custom purpose- ...
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Quality Engineer
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Quality Engineer
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Info Way Solutions Fremont, United StatesHiHope you are doing wellMy name is Dinesh ; I am a Technical Recruiter with Info Way Solutions LLC.I have a requirement of below position, share me the resume of your consultants accordingly.Please Find Required Details as well JD BelowJob Role - Quality Engineer III (US) - Mobi ...
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Quality Engineer
2 days ago
Info Way Solutions Fremont, United StatesHi · Hope you are doing well · My name is Dinesh ; I am a Technical Recruiter with Info Way Solutions LLC. · I have a requirement of below position, share me the resume of your consultants accordingly. · Please Find Required Details as well JD Below · Job Role - Quality Engi ...
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Quality Engineer
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DivIHN Integration, Inc Alameda, United States OTHER*Title: Quality Engineer* · Location: Alameda, CA · Duration: 12 Months with possible extension · *A detailed description of the position will be shared once we get your application* · *Quality Engineer* · Responsible for filing necessary applications and handling all government ...
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Quality Engineer
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Quality Engineer
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Quality Engineer
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Sanmina Newark, United StatesShare this job as a link in your status update to LinkedIn. · Category (For Job Seekers) · Quality · Location · Job Description · Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electro ...
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Quality Engineer
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Quality Engineer
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Senior Quality Engineer
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Software Quality Engineer
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Senior Quality Engineer
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Senior Quality Engineer
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Universal Scientific Industrial Co., Ltd. Fremont, United StatesUSI/Asteelflash is actively looking for a · Senior Quality Engineer · to join our Quality Team here in Fremont, CA. · The successful candidate will be responsible for ensuring the safety and quality of our products and procedures through rigorous inspections, implementation of ...
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Sr. Quality Engineer
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Sr. Quality Engineer
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Supernal Fremont, United StatesSupernal is at the forefront of creating emerging mobility solutions that will foster the development of human-centered cities. We are designing a completely new electric vertical take-off and landing (eVTOL) aircraft tailored to the mobility needs of future cities. This allows p ...
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Sr. Quality Engineer
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Test Dev Tools Fremont, United StatesSupernal is at the forefront of creating emerging mobility solutions that will foster the development of human-centered cities. We are designing a completely new electric vertical take-off and landing (eVTOL) aircraft tailored to the mobility needs of future cities. This allows p ...
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Quality Engineering Manager
3 days ago
Brooks Automation Fremont, United StatesAt Brooks, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. · All we accomplish is grounded ...
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Quality Engineering Manager
1 week ago
Brooks Automation Fremont, United StatesAt Brooks, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. · All we accomplish is grounded ...
Quality Engineer - Fremont, United States - Katalyst Healthcares and Life Sciences
Description
Summary:
Responsible for ensuring that materials, goods, and services meet Customer and Quality requirements. Maintains the Quality System to comply with regulatory requirements. Leads continuous quality improvement activities. This is a hands-on position that works with Customers and all functions and levels within the company.
Job Description:
Quality Management System Maintain the Quality Management System procedures and work. instructions to comply with Customer and Quality/Regulatory requirements. Work with all functions to ensure compliance with requirements. Supplier Management Manage the Supplier Management program.
Initiate Supplier Evaluations and perform Supplier Approvals Conduct Supplier Audits Maintain the Approved Supplier List Develop Supplier Quality Measures and work with Suppliers to improve performance.
Maintain an effective Supplier Corrective Action process. Identify opportunities for supply chain improvements. Implements process. improvement to increase quality and yields at suppliers. NCMR Manage the Non-Conforming Materials Process Works with Customers, Suppliers, and internal personnel to resolve. nonconforming materials issues Prepare non-conforming material reports and participate in subsequent. root cause investigation and corrective action planning. Incoming Inspection Participate in and support the Incoming Inspection function. Develop incoming Inspection requirements. Manages the Calibration and Preventive Maintenance process.Coordinates the calibration of equipment with the Calibration Service Works with personnel and Customers to ensure that all equipment is calibrated and maintained.
Ensure that all internal calibrations are performed per requirements. Participate in New Product Introduction teams to ensure customer and regulatory requirements are met.Manage the Corrective & Preventive Action System including responding to Customer Complaints Develop and prepare QMS metrics to monitor the performance of internal.
processes for Customers, and Management Manage the Document Control process for Quality Management System documentation. Prepare materials for, and participates in Management Reviews Facilitate the Internal Audit program and conduct audits of the QMS.Facilitate and manage Customer, Notified Body, and Regulatory Audits Work with all functions to ensure Training is conducted per requirements.
Performs Release to Finish Goods and Authorizations for Distribution Drives improvements by facilitating cost and quality improvement projects.Knowledge and Skills:
Demonstrated ability to work well in a cross-functional team environment and clearly communicate the status of assigned projects. Ability to work under tight deadlines and to handle multiple detail-oriented tasks simultaneously. Excellent oral, written, and people skills. Demonstrated high level of computer literacy - proficient in developing.
spreadsheets, utilizing word processing and databases (MS Office) Proficient in performing Corrective and Preventive Actions Proven analytical ability and attention to detail.
Ability to work proactively with suppliers to improve product quality and quickly. resolve quality issues. Understand and be proficient in the use of incoming inspection equipment. Knowledge of theory and application of principles of statistics, statistical sampling techniques, and statistical process control. Knowledge of, and experience with sterile medical device controls and requirements would be a benefit.Education and Experience Bachelor degree in Engineering, prefer Industrial, Manufacturing, or Mechanical 5 plus years of Quality Engineering experience Required Medical Device Experience Comprehensive knowledge of ISO 13485 and 21CFR820 Auditing experience is required.
In addition, experience with the following would be beneficial:Contract Manufacturing Lean Manufacturing Process Validations Software Validation Risk Management AS9100 ITAR RoHS