Quality Systems Specialist II: Medical Devices & Compliance
Element Science, Inc.
Element Science, Inc. is seeking a Quality Systems Specialist II to drive compliance and quality improvements for our medical device patch defibrillator. You will partner with Manufacturing, Regulatory, and R&D to advance CAPA, change control, NCRs, and post-market surveillance. The role requires a Bachelor's in a scientific or engineering field, 3+ years in medical device quality systems, ISO 13485 knowledge, and strong communication. #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... ...improvements and ensure regulatory compliance. The role focuses on complaint...Medical device
$87k - $100k
...Description Element Science, Inc. is a medical device and digital health company... ...SUMMARY OF ROLE: We are looking for a Quality Systems Specialist II with passion for creating devices... ...vital role in guiding teams, ensuring compliance with industry regulations, and...Medical deviceTemporary workLocal areaVisa sponsorshipWork visaRelocation packageFlexible hours$186k - $233k
...pathway.The Opportunity:Lead the Global Quality Systems Monitoring & Excellence program to ensure effective governance, compliance, and continuous improvement across the Quality... ...in the biotechnology, pharmaceutical, or medical device industry, including people leadership....Medical deviceFull timeLocal area$144k - $209k
...practical experience. 8 years of experience in quality engineering or systems architecture for software as a medical device or digital health products. Experience in... ...Reimagine how QMS can be achieved using to meet the compliance requirement. Participate in experimenting...Medical deviceShift work$45 - $65 per hour
...Description Job Description Job Title: Quality Systems Specialist Job Description The Quality Systems... ...support GxP operations, and maintain compliance with current Good Manufacturing... ...temporary role may include the following: • Medical, dental & vision • Critical Illness,...SuggestedContract workTemporary workWork at officeLocal area- Position: Manager - IT Business Systems Quality Location: Redwood City, CA Job Id: 249-113... ...Systems. Your Role: Assure that GxP compliance requirements are properly assessed, and... ...Sciences (Biotech, Pharmaceuticals, Medical Device) industry including implementation of...Medical device
- Corcept Therapeutics in Redwood City, CA, is seeking a Quality Specialist II, Quality Compliance, to perform day-to-day quality operations supporting clinical... ..., and external vendors to strengthen the quality system and readiness for inspections. This hybrid role requires...3 days per week
- ...Quality Systems Specialist III Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing standard operating procedures to ensure quality. Maintains programs and processes to ensure high quality products...
- Verily Health is seeking a Quality Systems and Compliance Lead to own one or more QA domains across consumer health, research tools, and medical devices. The role requires leadership of complex quality initiatives with regulatory impact. You will design, implement, and...Medical device
$90k - $105k
...Quality Control Analyst II, Analytical ( Newark, CA) Revance Therapeutics, Inc. JOB DESCRIPTION:... ...data to ensure accuracy and regulatory compliance. Support sample receiving, shipment to... ...products. # Microsoft Office, LIMS system, and data trending. # Data...Contract workInternshipWork at officeRemote work$25 - $28 per hour
...We design novel access device technology for vascular... ...Manufacturing Technician II / Catheter Assembly... ...Industry: Neurovascular Medical Devices (Catheters)... ...to meet safety and high-quality standards. We're looking... ...consistently follow FDA Quality Systems Regulations and ISO 134...Medical deviceHourly payFull timeMonday to FridayFlexible hoursShift work$20.75 - $41.45 per hour
...Customer Support Specialist II Abbott is a global healthcare leader that... ...products in diagnostics, medical devices, nutritionals and branded generic... .... Motivated to perform quality work; diligent about arriving... ...company's Quality Management System policies and procedures....Medical deviceHourly payMonday to FridayShift work$272k - $336k
...Waymo Systems Engineering Role Waymo is an autonomous driving technology company with... ...and Type Approval processes) to close compliance gaps Represent technical teams and... ...driving (ADS), aerospace, robotics, or medical device industries Experience successfully driving...Medical deviceOdd jobFull timeRemote work- ...Environmental Compliance Specialist Hims & Hers is seeking an... ...Business Plans (HMBPs), air quality, industrial... ...wastewater, stormwater, Tier II, California... ...chemical manufacturing, medical device, contract research, or... ...environmental management systems (e.g., ISO 14001),...Medical deviceFull timeContract workLocal area
$142k - $213k
...personalized, predictive, and precise. Description The Quality Systems and Compliance Lead drives quality excellence at Verily by owning one... ...products spanning consumer health, research tools, and medical devices are developed, commercialized, and sustained to the highest...Medical deviceFull time- ...CALIBRA Job DescriptionTitle: Sr. Quality Engineer for Swing Shift 2. Supervisor... ...: Supports production of clinical devices and process development. Maintains compliance to Medical Device Directives (MDD), ISO 13485, and Quality System Regulations for Design Controls....Medical deviceWork experience placementWork at officeAfternoon shift
- Siemens Healthineers in Palo Alto seeks a Systems Engineer for the radiation-producing subsystem of Radiation Oncology products. You will define requirements, lead integration, verification, and problem solving across a multidisciplinary team. The role demands strong systems...Medical device
- ...Careers That Change Lives Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With... ...checks on work in process and completed. May conduct quality inspections on processing line in accordance with quality specifications...Medical deviceTemporary workWork experience placementWork at officeLocal areaRemote workWorldwide
- ...and negatively impact quality of life. Position... ...Principal Regulatory Affairs Specialist drives the full... ...through post-market compliance, for Pulmonx's US and international device portfolio. This highly... ...specifically with Class II or Class III medical devices. Bachelor’s...Medical device
$291.72k - $343.2k
...departments towards achieving a high-quality (defined as first time... ...regulatory road maps for medical devices and preferably combination drug... ...assigned task. Ensure compliance with established regulations... ...with FDA Quality Management System Regulations (QMSR), ISO 1348...Medical deviceTemporary work$145k - $167k
...resonance brain imaging system capable of... ...Affairs Specialist advises regulatory... ...for the company’s devices and ensures compliance to Regulatory requirements... ...knowledge of Quality System standards... ...knowledge of medical device labeling... ...for Class II devices and interactions...Medical deviceWork experience placementWork at officeWorldwideWork visaNight shiftWeekend work3 days per week$265k - $331k
...Opportunity:The Executive Director, GxP Quality & Compliance is a senior leadership role... ...oversight of inspection readiness, quality systems, compliance risk management, supplier... ...within the pharmaceutical, biotechnology, medical device, or related life sciences industry...Medical deviceFull timeLocal area- ...grows, we improve the quality of life of patients,... ...Principal Regulatory Affairs Specialist provides regulatory... ...practices to ensure compliance with FDA and... ...would have had previous medical device experience and looking... ...BioRobotics Quality Management System to ensure product and...Medical deviceWork at office
- ...customers to provide optical systems, assemblies, and components... ...industries, with a history of quality and excellence that dates... ...assurance, continuous improvement, compliance and finance. The Role... ...(optics, aerospace, medical devices, defense, or similar) strongly...Medical device
$199.3k - $274.05k
...operational excellence, scalability, quality, regulatory compliance, and exceptional service levels.... ...experience with inventory management systems, ERP platforms, and warehouse management... ...laboratory services, biotechnology, medical device, pharmaceutical, or other regulated...Medical deviceFull timeWork at officeWork from home- ...process, financial reporting, payroll administration, compliance activities, and finance systems administration. Reporting directly to the CFO, this... ...candidate will bring hands-on experience in a venture-backed medical device, life sciences, or manufacturing environment, strong...Medical deviceFull time
- 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
$120k - $140k
...40,000.00 Annually Build the system that keeps innovation moving... ...technologies across semiconductors, medical, aerospace, solar, and... ...Supply Chain, Customer Service, Quality, and Finance. The Planning... ...center infrastructure, medical devices, pharma/biopharma equipment,...Medical deviceFull time$120k - $150k
...of the GxP Training Program within the Quality Systems function, ensuring training processes,... ...improvement initiatives that strengthen compliance and operational excellence.Design, develop... ..., age, disability, marital status, medical condition, and veteran status.Revolution...Full timeWork at officeLocal area- ...healthcare. We have the only system that can have safe,... ...regulatory strategy, filings, and compliance activities for (a) clinical... ...pharmaceuticals, biologics, and medical devices, and (b) AI-driven SaMD... ...timelines, and ensuring high-quality documentation. Translate...Medical deviceWork at office
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