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Quality Engineering Technician
1 week ago
Joby Aviation San Carlos, United StatesJoby Overview: Located in Northern California, the Joby Aviation team is steadily working toward our goal of creating an affordable, all-electric air transportation system. Imagine an air taxi that takes off vertically, then quietly and quickly carries you over the traffic conges ...
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Quality Engineering Technician Iii
3 days ago
Pulmonx Corporation Redwood City, United States**Pulmonx** is looking for a **Quality Engineering Technician III** to join and our team Who is **Pulmonx**? We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease. · **Resp ...
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Design Control Quality Engineer
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Actalent San Mateo, United States Full timeDescription: · • Act as a quality engineer for medical device QMS quality improvement activities, with a focus on design controls and risk management. · • Provide oversight of quality improvement activities and ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ...
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Quality Engineer
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Ryzen Solutions Redwood City, United StatesPosted: · 05/14/2024 · Pay Rate: · Pay: $70, $90,000.00 per year DOE · Job Description · Looking for a Quality Engineer at our Redwood City plant. The ideal candidate will have good understanding & knowledge of Quality Management System, especially ISO9001 and AS9100. Experie ...
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Quality Engineer
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Joby Aviation San Carlos, United StatesJoby Overview: · Located in Northern California, the team at Joby Aviation is driven by our goal of creating an affordable, all-electric air transportation system. Imagine a piloted air taxi that takes off vertically, then quietly carries you and your fellow passengers over the ...
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Apex Dynamics San Germán, United StatesAbout Rail Power Systems GmbH: · We ensure that trains get off to a good start - because we are a leading company in the planning and construction of railway electrification and power supply systems. And we have been doing this for over 130 years. · What do we offer? · 30 days of ...
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Quality Engineer
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Joby Aviation San Carlos, United StatesJoby Overview Located in Northern California, the team at Joby Aviation is driven by our goal of creating an affordable, all-electric air transportation system. Imagine a piloted air taxi that takes off vertically, then quietly carries you and your fellow passengers over the cong ...
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Quality Engineer
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Cloud Analytics Technologies LLC San Carlos, United StatesWork Authorization: · US Citizen, Green Card, H-1B, GC-EAD, OPT-EAD, L2-EAD, TN Visa · US citizens (USC) and Permanent Residents (GC) are encouraged to apply. We are unable to offer any sort of Visa sponsorship for this position. · Local Candidates Preferred. Non-local candidate ...
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Director, Quality Engineering
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Element Science Inc Redwood City, United StatesDIRECTOR, QUALITY ENGINEERING · THE COMPANY: · Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading c ...
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Director, Quality Engineering
1 week ago
Element Science Inc Redwood City, United StatesDIRECTOR, QUALITY ENGINEERING · THE COMPANY: · Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading c ...
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Senior Quality Engineer
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IdentifEye Inc. Redwood City, United StatesWho We Are · Join us on our mission to democratize access to the abundance of health information in the human eye Here at identifeye HEALTH Inc., we're pioneering a new branch in diagnostics between laboratory medicine and radiology, that will enable regular non-invasive health m ...
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Director, Quality Engineering
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Element Science Inc Redwood City, United StatesDIRECTOR, QUALITY ENGINEERING · THE COMPANY: · Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading ...
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Sr. Quality Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Redwood City, United StatesResponsibilities : Perform quality activities related to the IVD development activities which includes providing guidance for design controls, risk management, change control, and decisions on product development activities to ensure continued compliance with internal procedures ...
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Senior Quality Engineer
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identifeye HEALTH Inc. Redwood City, United StatesWho We Are · Join us on our mission to democratize access to the abundance of health information in the human eye Here at identifeye HEALTH Inc., we're pioneering a new branch in diagnostics between laboratory medicine and radiology, that will enable regular non-invasive health ...
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Senior Quality Engineer
1 week ago
identifeye HEALTH Inc. Redwood City, United StatesWho We Are · Join us on our mission to democratize access to the abundance of health information in the human eye Here at identifeye HEALTH Inc., we're pioneering a new branch in diagnostics between laboratory medicine and radiology, that will enable regular non-invasive health ...
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Staff Quality Engineer
3 weeks ago
HealthCare Recruiters International San Carlos, United StatesClient: · Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states. · Job Location: (Hybrid) Open to San Jose or San Carlos ...
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Quality Engineer Metrology
3 weeks ago
Path Engineering San Carlos, United StatesRole · As a Quality Engineer-Metrology (also known as Quality Control Engineer, Metrology Specialist), you'll develop and maintain inspection networks for new and existing products, interpret drawings and control plans, execute qualification plans, provide project status, suppor ...
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Quality Engineering Manager
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Penumbra Alameda, United States**What You'll Work On**: · - As a leader, manage the quality engineering functions in support of production to ensure conformance to the Penumbra Quality Management System, FDA QSR, ISO standards, and other regulatory requirements within a multidisciplinary team · - Direct manage ...
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Manager, Quality Engineering
1 week ago
Zoox San Carlos, United StatesZoox is building the quality team that will take our first-in-class autonomous robot from development to commercialization. As The Manager, Quality Engineering, you will be responsible for leading the Advanced Hardware Manufacturing Operations quality team members and ensuring th ...
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Quality Engineer-CMM
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PDS Tech Commercial, Inc. San Carlos, United StatesPDS Tech Commercial, Inc. is seeking candidates for a Quality Engineer - Inspection Lab Measurement/CMM in San Carlos, California. · Job Title: Quality Engineer - Inspection Lab Measurement/CMM · Job Type: 7 mo+ CONTRACT Assignment - possibility of Temp-to-Perm · Location: San ...
Sr. Quality Engineer - Redwood City, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities :
Perform quality activities related to the IVD development activities which includes providing guidance for design controls, risk management, change control, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations.
Ensure required documentation is completed prior to product transfers and product launches.
Provide guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities.
Facilitate risk management and change control activities.
Support processes such as document control, training, CAPAs, and developing quality metrics.
Identify opportunities for continual improvement and works with management and team members to successfully address these opportunities.
Develop and maintain organized records that demonstrate compliance to all company processes, regulations, and the company's QMS.
Perform and document internal audits and make recommendations for corrective actions.
Perform other related duties and responsibilities as assigned.
Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
Requirements :
Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.
5+ years of quality experience in an FDA/ISO regulated environment.
Experience in molecular biology products or molecular diagnostic products.
Knowledge of applying statistical analysis for testing, process control, and design of experiments.
Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments.
Ability to successfully balance and prioritize multiple ongoing projects and tasks in a fast-paced, deadline driven environment.
Excellent problem-solving and analytical skills.
Effective communication and interpersonal skills.
ASQ CQE certification is preferred.
May be required to lift routine office supplies and use office equipment.
The majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment.
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