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Data Engineer III: ensuring quality data
2 weeks ago
Talentry Carlsbad, United StatesThis is a remote position. · Data Engineer III: ensuring quality data. · Carlsbad, CA (Remote work possible) · Direct-hire k. US Citizen/Green Card only · This position requires a US Citizen or Green Card Holder only, and is a direct hire position. No third party candidates will ...
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Quality Engineer
5 days ago
Abbott Laboratories company Carlsbad, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Quality Engineer
1 week ago
Abbott Laboratories company Carlsbad, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Quality Engineering
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Orthofix Carlsbad, United StatesWhy Orthofix? · We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, w ...
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Quality Engineer
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Alphatec Spine Carlsbad, United StatesDevelop and improve, with an emphasis on implementation, inspection methods, gages, process control techniques, standard operating procedures, inspection plans, test protocols and test reports to ensure safety, reliability and efficacy of new products and processes.Essential Duti ...
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Quality Engineer
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Internetwork Expert Inc Carlsbad, United StatesDevelop and improve, with an emphasis on implementation, inspection methods, gages, process control techniques, standard operating procedures, inspection plans, test protocols and test reports to ensure safety, reliability and efficacy of new products and processes. · Essential D ...
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Quality Engineer
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Alphatec Spine Carlsbad, United StatesDevelop and improve, with an emphasis on implementation, inspection methods, gages, process control techniques, standard operating procedures, inspection plans, test protocols and test reports to ensure safety, reliability and efficacy of new products and processes. · Essential ...
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Quality Engineer
1 week ago
Alphatec Spine Carlsbad, United StatesJob Description · Job DescriptionDevelop and improve, with an emphasis on implementation, inspection methods, gages, process control techniques, standard operating procedures, inspection plans, test protocols and test reports to ensure safety, reliability and efficacy of new prod ...
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Quality Assurance Engineer
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Legrand NA Carlsbad, United StatesPosition Description · At a Glance · Legrand has an exciting opportunity for a Quality Assurance Engineer to join the WattStopper Team in Carlsbad, CA. · What Will You Do? · Role:As a Quality Assurance Engineer II, you will be responsible and accountable for implementing quality ...
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Quality Assurance Engineer
2 weeks ago
Legrand North America Carlsbad, United StatesPosition Description · At a Glance · Legrand has an exciting opportunity for a Quality Assurance Engineer to join the WattStopper Team in Carlsbad, CA. · What Will You Do? · Role: As a Quality Assurance Engineer II, you will be responsible and accountable for implementing qualit ...
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Software Quality Engineer,
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Axelon Carlsbad, United StatesTitle: Software Quality Engineer · Location: San Diego, CA · Hours: 8:00AM - 5:00PM · Max pay : $53/hr. · This is a non-exempt position. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for ...
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Supplier Quality Engineer
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QuidelOrtho Carlsbad, United StatesThe Opportunity · QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are m ...
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Quality Systems Engineering
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Orthofix Holdings, Inc. Carlsbad, United StatesQuality Systems Engineering - Intern page is loaded · Quality Systems Engineering - Intern · Apply · locations · Carlsbad · time type · Full time · posted on · Posted 3 Days Ago · job requisition id · OFX24166 · Why Orthofix? · We are a leading global spine and orthop ...
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Lead, Quality Engineer
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L3Harris Technologies Carlsbad, United StatesThe Program Quality Engineer function is a program focused role that is responsible for ensuring product quality and contractual requirements are met. This includes ensuring/verifying the quality of product inputs such as hardware design, software de Quality Engineer, Engineer, Q ...
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Quality Systems Engineering
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Orthofix Carlsbad, United StatesWhy Orthofix? · We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, w ...
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Supplier Quality Engineer
1 week ago
QuidelOrtho Carlsbad, United StatesThe Opportunity · QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are m ...
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Senior Quality Engineer
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CARLSMED, Inc. Carlsbad, United StatesJob Description · Job Description Salary: · About Carlsmed · Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The Carlsmed aprevo personalized surgery platform is designed to improve the standard of care for spine surgery one ...
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Quality Systems Engineering
3 weeks ago
Orthofix Carlsbad, United StatesWhy Orthofix? · We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, w ...
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Software Quality Engineer
2 weeks ago
Nordson Carlsbad, United StatesCollaboration drives Nordson's success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers ...
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Supplier Quality Engineer
1 week ago
Ortho Clinical Diagnostics Carlsbad, United States Full timeThe Opportunity · QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are m ...
Quality Engineer - Carlsbad, United States - Bolt Medical, Inc.
3 weeks ago
Description
ABOUT THE COMPANY
A medical device startup company at the transition from R&D and is working on a family of therapeutic medical devices that will save people's lives.
Our company has an exciting and unique technology with clinical advantages over existing procedures. It is uniquely positioned for success and is led by veterans in the industry.Job Summary:
The position will be responsible for providing quality engineering support.
This position will work closely with R&D, Manufacturing in the design and manufacture of disposable medical catheters and console in compliance with applicable regulatory and statutory requirements.
Essential responsibilities:
Conduct product returned investigations and ensure rapid resolution of product investigation and/or safety issues with cross functional group
Support master validation process and documentation including the validations of Production processes and tooling documentation, MVP, IQ, OQ, PQ, PPQ, and TMV
Support approved Operations initiatives.
Review and audit medical device records for comprehensiveness.
Develop, review, and approve inspection plans and product drawings for new or modified product designs for quality characteristics
Ensure that the contents of DMR and DHR are accurately developed and verified.
Implement a risk-based approach to ensure product conformance with customer needs.
Recommend and provide statistical support and expertise and analytical problem solving for product development and manufacturing.
Lead the resolution of quality issues related to NCR and CAPA.Take appropriate actions to address the nonconformance of supplied goods and services.
Develop activities that would drive prevention, detection of defects at earliest phase of product design.Assist in the investigation, root cause analysis, planning, and execution of activities within the CAPA system.
Ensure robust final product testing is designed, developed, and implemented.
Review all design changes to ensure that the documentation includes the necessary justifications, validation and verification updates, risk assessment etc.
Supports activities related to Management Review, audits (internal and external), deviations, CAPA, NCR, supplier management, RGA, and etc.Identify improvement opportunities related to the quality system and product
Responsible for compliance with quality system procedures and all regulatory requirements.
Required Knowledge and Experience:
Bachelor's degree in a scientific/engineering discipline; or equivalent combination of education and experience.
Minimum 2 year (QE II) or 5 year (Senior QE) of relevant work experience in either pharmaceutical, medical device, or other highly regulated industry.
Knowledge, Skills, and Abilities:
Experience working in medical devices, while working within Quality is required.
GMP experience working within ISO 13485 and FDA 21 CFR Part 820 environments.
Capable of reviewing and interpreting drawings
Experience in performing test method validation and Gage R&Rs is preferred
In-depth understanding of statistical techniques such as normality analysis, tolerance analysis, and should be able to analyze and interpret data with high confidence.
Must know how to use Minitab or other statistical softwareStrong 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 (Word, Excel, Power Point, Project, Visio)
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