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Quality Engineer United States Jobs

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Hardware Quality Engineer
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Join our team in Louisville, CO as a Hardware Quality Engineer. You will apply your 4+ years of experience to ensure quality throughout the product lifecycle, from design to manufacturing. Key duties include developing test protocols, statistical analysis, and supporting design history files. Thi...
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United States , Louisville, Colorado
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35.00 - 38.00 USD / Hour
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MillenniumSoft Inc
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Principal Quality Engineer
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Join our team in San Diego as a Principal Quality Engineer. You will lead the remediation of medical device Risk Management Files to achieve ISO 14971:2019 compliance. This role involves updating hazard analyses and collaborating cross-functionally. Ideal candidates have 5+ years' experience in a...
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United States , San Diego
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55.00 - 60.00 USD / Hour
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MillenniumSoft Inc
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Senior Firmware Quality Engineer
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Join our firmware team as a Senior Firmware Quality Engineer in San Jose. You will design and execute test plans for embedded systems in an agile environment. This role requires 3+ years of firmware test development, proficiency in C#, and expertise in test automation. Be a key technical voice, e...
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United States , San Jose
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48.00 - 52.00 USD / Hour
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MillenniumSoft Inc
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Supplier Quality Engineer
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Join our team as a Supplier Quality Engineer in Zelienople. You will manage supplier selection, qualification, and monitoring within the medical device sector. This role requires 1-3 years' regulated industry experience and knowledge of ISO-13485. Support new product introduction and continuous i...
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United States , Zelienople
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27.00 - 32.00 USD / Hour
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MillenniumSoft Inc
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Senior Quality Engineer
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Join our team as a Senior Quality Engineer in Vernon Hills. You will ensure supplier quality and manage specifications for FDA-regulated medical devices. A BS in Engineering and 3+ years in a regulated industry are required. ASQ certification is a strong advantage for this hands-on role.
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United States , Vernon Hills
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45.00 - 47.00 USD / Hour
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MillenniumSoft Inc
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Quality Engineer
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Join our team as a Quality Engineer in Franklin Lakes, US. You will apply your intermediate knowledge of cGMP, FDA, and ISO regulations to validate equipment and processes. Key duties include writing test protocols, performing statistical analysis, and resolving production issues. This role offer...
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United States , Franklin Lakes
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30.00 - 34.00 USD / Hour
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MillenniumSoft Inc
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Mdr quality engineer
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Join our team as a Medical Device Quality Engineer in Louisville. You will ensure software quality for patient temperature management systems, supporting the full development lifecycle. This role requires 5-7 years of medical device software testing experience and deep knowledge of FDA, ISO, and ...
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United States , Louisville
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35.00 - 39.00 USD / Hour
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MillenniumSoft Inc
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EUMDR Quality Engineer
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Join our team in Louisville as an EUMDR Quality Engineer. You will manage regulatory records, conduct gap assessments, and track mitigation tasks to ensure compliance. This role requires experience with pre-clinical/clinical data and a Bachelor's Degree. Collaborate with cross-functional teams to...
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United States , Louisville
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54.00 - 59.00 USD / Hour
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MillenniumSoft Inc
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Quality Engineer
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Join a leading Medical Devices company in Andover as a Quality Engineer. You will perform critical Test Method Validations, IQ/OQ/PQ, and FMEA activities in compliance with ISO 13485 and ISO 14971. This role requires a Bachelor's degree and hands-on experience with Minitab software and FDA CFR 82...
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United States , Andover
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65.00 - 70.00 USD / Hour
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MillenniumSoft Inc
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Quality Engineer
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Join our team in Sparks, MD as a Quality Engineer. You will apply cGMP/FDA/ISO knowledge to validate products, resolve process issues, and handle complaints. This role involves writing test protocols, analyzing data, and working cross-functionally. A Bachelor's degree and foundational quality eng...
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United States , Sparks, MD
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30.00 - 35.00 USD / Hour
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MillenniumSoft Inc
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Sr Quality Engineer
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Join BD as a Senior Quality Engineer in San Diego. You will apply your expertise in medical device quality systems, including ISO 13485, validation (IQ/OQ/PQ), and nonconformance/CAPA management. This role supports new product development and sustaining activities, requiring strong design control...
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United States , San Diego
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38.00 - 41.00 USD / Hour
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MillenniumSoft Inc
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Senior Software Quality Engineer
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Join our growing team in San Jose as a Senior Software Quality Engineer. You will develop and execute test strategies for complex medical device software, primarily using C++/C#. This role requires Agile/Scrum experience, test automation skills, and a passion for creating life-saving healthcare t...
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United States , San Jose
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48.00 - 52.00 USD / Hour
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MillenniumSoft Inc
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Quality Engineer
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Join our team in Tempe as a Quality Engineer, focusing on new product transfer from design to manufacturing. You will apply your 2-4 years of medical device experience and knowledge of FDA/ISO standards to resolve production issues and lead validation activities. This role involves cross-function...
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United States , Tempe
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40.00 - 43.00 USD / Hour
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MillenniumSoft Inc
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Quality Engineer
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Join our team in Andover as a Quality Engineer specializing in Class II Medical Devices. You will lead Design Transfer activities per FDA CFR 820, utilizing Minitab for analysis and validation. Your role is critical in executing Test Method Validations, IQ/OQ/PQ, and FMEAs in compliance with ISO ...
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United States , Andover
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65.00 - 70.00 USD / Hour
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MillenniumSoft Inc
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Sr Hardware Quality Engineer
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Seeking a Senior Hardware Quality Engineer in Louisville, KY or Vernon Hills, IL. You will ensure FDA-regulated quality, support design control, and manage validations. A BS in Engineering and experience in medical device development are required. ASQ certification is a strong plus.
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United States , Louisville, KY; Vernon Hills, ILLINOIS
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48.00 - 52.00 USD / Hour
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MillenniumSoft Inc
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Quality Engineer
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Join our team as a Quality Engineer in San Jose. You will ensure cGMP compliance, oversee quality notifications, and conduct complaint investigations for instrument product lines. The role requires a BS/BA with 2+ years' experience and strong knowledge of FDA/GMP regulations. Ideal candidates are...
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United States , San Jose
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34.00 - 38.00 USD / Hour
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MillenniumSoft Inc
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Sr Hardware Quality Engineer
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Seeking a Senior Hardware Quality Engineer in Louisville. This role supports quality assurance and design control for medical devices within an FDA-regulated environment. Ideal candidates have a BS in Engineering, 1+ years of industry experience, and strong knowledge of validation protocols and r...
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United States , Louisville
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34.00 - 39.00 USD / Hour
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MillenniumSoft Inc
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Quality Engineer
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Join our San Diego team as a Quality Engineer II, specializing in validation for medical devices. You will execute IQ/OQ/PQ protocols, ensure ISO 13485 compliance, and manage nonconformances. The role requires 3-5 years in Pharma/Biotech, strong technical writing, and expertise in quality systems...
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United States , San Diego
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Not provided
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MillenniumSoft Inc
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Quality Engineer
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Join our team in Mannford, OK as a Quality Engineer. You will ensure product quality and compliance with FDA/ISO standards in the medical device/pharma sector. Key duties include validation, statistical analysis, and cross-functional collaboration. A BS degree and 2+ years of GMP experience are r...
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United States , Mannford, OK
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Not provided
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MillenniumSoft Inc
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Quality Engineer
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Join our team as a Quality Engineer in Covington, USA. You will ensure product and service quality through validation, statistical analysis, and cross-functional collaboration. This role requires basic FDA/ISO knowledge and experience with test protocols. US Citizenship or Green Card is mandatory.
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United States , Covington
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Salary
22.00 - 28.00 USD / Hour
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MillenniumSoft Inc
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Explore a world of opportunity in Quality Engineer jobs, a critical and rewarding profession dedicated to ensuring excellence, reliability, and customer satisfaction across virtually every industry. A Quality Engineer (QE) is a professional guardian of standards, operating at the intersection of design, development, and manufacturing to build quality into products and processes from the ground up. Their work is systematic and proactive, focused on preventing defects rather than simply finding them, making them invaluable assets in today's competitive market. The day-to-day responsibilities of a Quality Engineer are diverse and impactful. Typically, they are responsible for developing and implementing robust quality assurance systems and protocols. This involves creating detailed test plans, designing and executing test cases, and developing sophisticated automation frameworks to efficiently validate product functionality, performance, and security. They conduct rigorous audits of processes and suppliers, analyze complex data for trends, and lead root cause analysis investigations using methodologies like 8D or CAPA (Corrective and Preventive Action) to resolve issues permanently. A significant part of their role is creating and managing essential quality documentation, including control plans, process failure mode effects analyses (PFMEAs), and production part approval process (PPAP) submissions. They collaborate closely with cross-functional teams, including design, development, and manufacturing engineers, to ensure quality considerations are integrated throughout the entire product lifecycle. To excel in Quality Engineer jobs, individuals typically possess a strong blend of technical and soft skills. A bachelor's degree in engineering, computer science, or a related field is a common requirement. Technically, proficiency is needed in precision measurement tools, statistical analysis software, and quality management systems (QMS). For software-focused roles, strong coding skills in languages like Python or Java, experience with automation tools like Selenium or Pytest, and a deep understanding of CI/CD pipelines are paramount. In manufacturing environments, knowledge of industry-specific standards such as ISO 9001, AS9100, or IATF 16949 is often essential. Beyond technical expertise, successful Quality Engineers are exceptional problem-solvers with a keen analytical mind and meticulous attention to detail. They are effective communicators who can clearly articulate issues, influence stakeholders, and write comprehensive reports. A proactive mindset, a passion for continuous improvement, and a relentless focus on the customer are the hallmarks of a top-tier professional in this field. Whether you are a seasoned expert or an aspiring candidate, Quality Engineer jobs offer a dynamic career path where your work directly shapes product integrity and builds brand trust. This profession is ideal for those who derive satisfaction from creating flawless user experiences and driving operational excellence through disciplined, data-driven processes. Discover your next career move and find the Quality Engineer jobs that match your skills and ambitions.

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