Quality Systems Specialist II - Medical Device QMS & CAPA
Element Science, Inc.
Element Science, Inc. is a medical device and digital health company focused on improving care for patients transitioning from hospital to home. We are seeking a Quality Systems Specialist II to drive CAPA investigations, change control, NCR management, and other QMS initiatives across cross-functional teams. You will help ensure ISO 13485 and QMSR compliance, support internal and external audits, review QMS documents, and mentor staff on quality processes while contributing to continuous #J-18808-Ljbffr Element Science, Inc.
- Element Science, Inc. is seeking a Quality Systems Specialist I to support CAPA processes and QMS activities in a fast-paced medical device environment. You will work cross-functionally with Manufacturing Engineering, Regulatory Affairs and R&D to drive quality improvements...Medical device
$87k - $100k
Element Science, Inc. is a medical device and digital health company... ...ROLE We are looking for a Quality Systems Specialist II with passion for creating devices... ...Report) Management, CAPA (Corrective and Preventive... ...and ensure compliance with QMS requirements. Review ECOs as...Medical deviceTemporary workLocal areaVisa sponsorshipWork visaRelocation packageFlexible hours$144k - $209k
...development of the most efficient way to use QMS to meet regulatory expectations.Create a system that can meet audit ready standards... ....8 years of experience in quality engineering or systems architecture for software as a medical device or digital health products....Medical deviceShift work$186k - $233k
...Opportunity:Lead the Global Quality Systems Monitoring & Excellence program... ...Quality Management System (QMS).Drive global audit and... ...sustainable improvements.Oversee CAPA governance related to... ...biotechnology, pharmaceutical, or medical device industry, including people...Medical deviceFull timeLocal area$91.1k - $125.3k
...Facebook. Position Summary:The Clinical Quality Engineer II plays an integral role on the Quality... ...activities that comply with the FDA’s Quality System Regulation and ISO 13485 . The Clinical... ...standard operating procedures / other QMS documentation as neededEnsures required...SuggestedFull timeWork at officeWork from home$186k - $233k
...Opportunity: Lead the Global Quality Systems Monitoring & Excellence... ...Quality Management System (QMS). Drive global audit and regulatory... ...improvements. Oversee CAPA governance related to internal... ..., pharmaceutical, or medical device industry, including people leadership...Medical deviceFull timeLocal area- ...deliver reliable, high-quality solutions—from product... ...package, including medical, dental, and vision coverage... .... Job Title: Quality System Specialist Job Function: Quality... ..., and maintain QMS, EMS, OHSMS, and ISMS... ...and preventive actions (CAPA) related to management...
- ...WILL BRING TO THE TEAM The Sr. Quality Systems Specialist will be responsible for... ...Quality Management System (QMS) in compliance with ISO 1348... ...Corrective and Preventive Action (CAPA), maintaining supplier files... ...opportunity, stock options, medical/dental/vision, 401(k) (with...Full timeContract workTemporary work
- Verily Health is seeking a Quality Systems and Compliance Lead to own one or more... ...health, research tools, and medical devices. The role requires leadership of... ...implement, and maintain a robust QMS aligned with ISO 13485:2016, drive CAPA programs, and coordinate with engineering...Medical device
$20.75 - $41.45 per hour
...products in diagnostics, medical devices, nutritionals and... ...Laboratory Technician II-GHI is responsible for... ...laboratory information system (LIMS), to review, enter... ...Comply with ISO 15189 and QMS. Record data adhering... ...and proactively raise quality concerns events, when necessary...Medical deviceHourly payWork at officeFlexible hoursShift workNight shiftWeekend work$30 - $40 per hour
...flexibly through the vascular system, then locks into place to... ...stability and control. Our device solves one of the longest-... ...is led by a proven team of medical device entrepreneurs and backed... .... Position Overview The Quality Control Specialist is primarily responsible...Medical deviceTemporary workWork experience placementWork at officeLocal area- Position: Manager - IT Business Systems Quality Location: Redwood City, CA Job Id: 249-1135... ...Life Sciences (Biotech, Pharmaceuticals, Medical Device) industry including implementation of... ...Experience with Veeva Vault (Quality Docs, QMS) preferred. Experience with Computer...Medical device
$120k - $150k
...of the GxP Training Program within the Quality Systems function, ensuring training processes, curricula... ...platforms (QualityDocs, Training, QMS).Proficient with Microsoft Office... ...ancestry, age, disability, marital status, medical condition, and veteran status.Revolution...Full timeWork at officeLocal area$20.75 - $41.45 per hour
...Customer Support Specialist II Abbott is a global healthcare leader... ...and products in diagnostics, medical devices, nutritionals and branded... ...independently. Motivated to perform quality work; diligent about... ...'s Quality Management System policies and procedures....Medical deviceHourly payMonday to FridayShift work$142k - $213k
...and precise. Description The Quality Systems and Compliance Lead drives... ...health, research tools, and medical devices are developed, commercialized... ...Quality Management System (QMS) — spanning consumer, research... ...and preventive actions (CAPA). Staffs and develops their...Medical deviceFull time- ...Careers That Change LivesOur space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote... ...checks on work in process and completed.May conduct quality inspections on processing line in accordance with quality specifications...Medical deviceTemporary workWork at officeLocal areaRemote workWorldwide
$30 - $35 per hour
...Manufacturing Assembler II Company Summary:... ...flexibly through the vascular system, then locks into place... ...and control. Our device solves one of the longest... ...by a proven team of medical device entrepreneurs and... ...assembling complex, high-quality catheter-based medical...Medical deviceTemporary workWork experience placementWork at officeLocal areaShift work- ...Mechanical Engineer - Robotic Systems for the Ottava Team. This is... ...of the world's most advanced medical robotic platforms. You will work... ...support of regulated medical devices. The ideal candidate has a... ...engineering, robotics and controls, quality, manufacturing, and...Medical deviceFull timeLocal area
$38 - $43 per hour
QA Analyst II Hybrid Summary The main function of a QA analyst is to develop and execute... ..., scenarios, scripts or procedures. Test system modifications to prepare for... ...benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental...Hourly pay$180k - $210k
...Product Info Well-funded medical device startup (~5 people)... ...Implantable cardiac diagnostic system for heart failure. The... ...’re seeking a hands‑on Quality & Design Assurance Lead to own our QMS and Design Quality. The... ...Internal and external audits, CAPA, NCRs, Supplier Quality,...Medical deviceFull timeH1bLocal area$265k - $331k
...Executive Director, GxP Quality & Compliance is a... ...inspection readiness, quality systems, compliance risk... ...Quality Management System (QMS), including policies, procedures... ...on deviation, CAPA, and quality event governance... ..., biotechnology, medical device, or related life sciences...Medical deviceFull timeLocal area- VP of Operations | Medical Device StartupA venture-backed medical device company developing innovative... ...infrastructure, supply chain strategy, quality systems, and operational processes capable of... ...volumes• Strong knowledge of Class II medical devices, ISO 13485, and FDA...Medical device
$40 - $50 per hour
...the globe. Adverum is seeking a dedicated Quality Control Analyst to be a part of our... ...QC) review of different assay techniques, systems, policies, processes, procedures, and controls... ...a minimum of 3‑5 years of experience (QC II) or 3‑5 years’ experience (QC III),...Contract work$130k - $165k
...re looking for a Senior Quality Engineer to own quality on a mid-field MRI system as we drive toward a 51... ...into a safe, cleared medical device — and you'll set the standard... ...Own and drive NCRs, CAPAs, deviations, and design... ...of ISO 13485 (QMS), ISO 14971 (risk management...Medical deviceRelocation package$151k - $176k
...Vaxcyte is seeking a Manager, Quality Assurance, Compliance who is... ...strategic oversight of key Quality System processes, with a primary... ...linkage between deviations, CAPA, and change controls to... ...pharmaceutical, biotechnology, or medical device industry. Other combinations...Medical device$40 - $45 per hour
...technology organization, is seeking a QA Analyst II to join their team. As a QA Analyst II, you will be part of the Quality Assurance department supporting cross-... ...waiting period, consultants are eligible for: ~ Medical and Prescription Drug Plans ~ Dental Plan...Hourly payWeekly payTemporary workFlexible hours$78 - $83 per hour
...Overview Senior Systems Process Engineer — Palo Alto, CA — Duration: 5 month contract... ...cross-functionally with homologation, quality, systems architecture, integration, hardware... ...Mobility, aerospace, space systems, or medical devices is highly valued—particularly where...Medical deviceContract work- ...Redwood City locations.As a Senior Quality Engineer, you will:Lead verification... ...validation and maintenance of host systems supporting Tempus Medical Device(s).Lead risk assessments to determine... ...CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and...Medical deviceFull timeWork at officeRemote work3 days per week
- ...seeking a Staff Mechanical Engineer to design and develop mechanical components and assemblies for Class III implantable neuromodulation systems and related external accessories. This hybrid role requires working 3x per week onsite. You will lead cross-functional teams,...Medical device
$75k - $80k
...looking for a QA Test Analyst II to join our growing team in Burlingame... ...on mobile or standalone devices (preferably Android-based), as... ...features. * Identify key quality challenges and goals, develop... ...enterprises deploy and scale complex systems with greater confidence....Full timeLocal area
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