Overview Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral …
Overview Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral …
Quantum-Art is a full-stack quantum computing company developing state-of-the-art quantum computing systems based on trapped-ion technology, encompassing both hardware and software. As part of our mission, the Theory and…
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Research Data Scientist, Brand Bidding Optimization, YouTube Ads
Mountain View, California, United States · On-site
$147k–$211k/yr
Mid level$26M raised
Minimum qualifications: Master's degree in Statistics, Data Science, Mathematics, Physics, Economics, Operations Research, Engineering, or a related quantitative field. 3 years of work experience using analytics to solve…
Skills: Python, R, SQL, Statistics, Data Science
Science Exchange, Inc.
Customer Operations Analyst — Japanese Langua
San Francisco, California, United States · Remote OK
$65k–$80k/yr
Mid level
About the Role We are looking for a Customer Operations Analyst with Japanese language fluency to join our Customer Operations team at Science Exchange. In this role, you will be a frontline resource for our customers &m…
Skills: Japanese Fluency, Customer Support, Technical Troubleshooting, Salesforce, Ticket Management
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About Majestic Labs We’re a fast-moving, US-Israeli AI startup building next-generation infrastructure for the world’s most demanding AI workloads. Our mission is to accelerate the future of intelligence and make it ubiq…
About Majestic Labs We’re a fast-moving, US-Israeli AI startup building next-generation infrastructure for the world’s most demanding AI workloads. Our mission is to accelerate the future of intelligence and make it ubiq…
Skills: C Programming, Assembly Language, Computer Architecture, Firmware Development, Linux Kernel Drivers
About Majestic Labs We’re a fast-moving, US-Israeli AI startup building next-generation infrastructure for the world’s most demanding AI workloads. Our mission is to accelerate the future of intelligence and make it ubiq…
Mountain View, California, United States · On-site
$207k–$301k/yr
Senior+$26M raised
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Mountain View, California, United States · On-site
$159k–$231k/yr
Senior$26M raised
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Test Engineer (Energy Storage and Distribution Systems)
San Carlos, California, United States · On-site
$104k–$144k/yr
Senior$4.2B raised
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Optum Tech is a global leader in health care innovation. Our teams develop cutting-edge solutions that help people live healthier lives and help make the health system work better for everyone. From advanced data analyti…
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The Division of Hematology, Oncology, Stem Cell Transplantation and Regenerative Medicine in the Department of Pediatrics at Stanford University is seeking board certified/eligible applicants with clinical expertise in p…
Mountain View, California, United States · On-site
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LISI AEROSPACE is ranked 60th in the global aerospace value chain and specializes in the design and manufacture of high-tech metal components to enhance aircraft safety and performance. Active since 1950 in the fastener …
Description Join a company transforming how the world understands microbes. Biolog is a global innovator in microbial identification, phenotypic cell profiling, and metabolic fingerprinting, fueling faster and smarter br…
Job Summary: Under the direction and oversight of the Laboratory Director and Laboratory Manager, or designee, within the scope of Unlicensed Laboratory Personnel as described in B&PC 1269, receives and processes specime…
Skills: Phlebotomy, Specimen Processing, Asepsis, Clerical Tasks, Medical Documentation
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Full-time
bachelor degree
Posted 15d ago
Apply by Jul 20
~40 hrs/week
Responsibilities
The Quality Engineer I ensures medical devices meet high quality standards by developing and improving quality management systems. They collaborate with cross-functional teams to perform risk assessments, root cause analysis, and maintain regulatory compliance.
Requirements
Requires a Bachelor's degree in Mechanical, Biomedical, or Industrial Engineering with at least 2 years of medical device production experience. Candidates must be fluent in English and capable of traveling up to 20% of the time.
Full job description
Overview
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.
Responsibilities
The Quality Engineer I will be responsible for ensuring that our medical devices meet the highest quality standards throughout the process. The QE I will be responsible for supporting the team through production scale up and associated quality deliverables. The primary focus will be ensuring that our processes and products meet established quality standards through developing, implementing, and continuously improving quality management systems, ensuring compliance with regulations, standards, and customer requirements. The position will collaborate with cross-functional teams to help identify quality issues, drive process improvements, and champion a culture of quality excellence.
Quality Control: Monitor and implement quality control measures (including verification of materials, components, and finished products) at every stage of the process, ensuring compliance with regulatory standards and internal quality requirements.
Process Improvement: Continuously identify and implement process improvements to enhance product quality, reduce waste, and optimize efficiency.
Design control: Work closely with R&D engineers to ensure design control is followed.
Risk Assessment: Prepare risk assessment documentation related to processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices.
Regulatory Compliance: Stay up to date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that processes adhere to these regulations.
Root Cause Analysis: Participate in root cause analysis for quality issues and recommend / implement corrective actions.
Documentation: Assist in maintaining accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with company standards.
Data Analysis: Analyze process data and quality metrics to identify trends and areas for improvement.
Strategic Impact
Quality support to sustaining current process.
Quality leads to support and implementation of revised QS
Key Interactions
Report on Quality Engineering.
Potential to interact with all functions including suppliers and customers depending on the topic/project being led or supported.
Qualifications
Required Skills and Experience
Bachelor’s degree in mechanical engineering, Biomedical or Industrial Engineering, or other related engineering fields.
2+ years in medical device production or previous internship or co-op experience in quality assurance or is a plus.
Previous experience working in a clean room environment [preferred]
Strong engineering background
Strong analytical and problem-solving skills.
Strong communication skills.
Excellent attention to detail and organizational skills.
Ability to work collaboratively in a team environment.
Fluent in English
Physical Requirements
Light office work and telecommuting capability.
Available to travel 20% of the time, as required domestic and international.
Must be able to lift and carry up to 50 lbs.
Pay / Compensation The expected pre-tax pay rate for this position is $68,200 - $84,700. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Related keywords
Medical DeviceQuality EngineeringQSClean RoomRegulatory StandardsRisk MitigationCorrective ActionsProcess DataQuality MetricsDrug Device Combination ProductsCoronary Artery DiseasePeripheral Artery DiseaseVerificationSustaining Process
From the first guidewire to the first drug eluting stent, for over 60 years Cordis has remained at the heart of cardiovascular innovation. Cordis is again at the forefront of transformation in the cardiovascular space, leveraging internal development, partnership with the CordisX innovation incubator and targeted acquisitions of industry-disrupting technology. These innovations, brought to market with the strength of Cordis’ global footprint and operations, seek to transform the interventional space through enhanced clinical outcomes, customer-centric services, and impactful educational platforms – doubling-down on our commitment to the interventional community. Cordis will Go Beyond, to relentlessly pursue our dedication to transform cardiovascular care.
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