Senior Quality Engineer - Medical Devices & CAPA Lead
Intuitive Surgical, Inc.
Intuitive Surgical, Inc. in Sunnyvale, CA, seeks a Senior Quality Engineer to oversee end-to-end quality investigations across manufacturing, supplier, and design activities. You will lead CAPA, risk assessment, and regulatory readiness, mentoring junior engineers and ensuring GMP/ISO/FDA compliance across the Endoluminal product family. The role emphasizes cross-functional leadership, data analysis, and effective communication with stakeholders to drive sustainable quality improvements in a #J-18808-Ljbffr Intuitive Surgical, Inc.
- Intuitive Surgical is seeking a Senior Quality Engineer to oversee end-to-end quality investigations across design, manufacturing... ...within the Endoluminal product family. You will lead cross-functional teams, drive CAPAs, and ensure regulatory compliance. The role emphasizes...Senior
- ...global leader in robotic-assisted surgery, seeks a senior QA/QA engineer to oversee end-to-end quality investigations across multiple operations and product families. You will lead cross-functional teams, drive CAPA and risk assessment activities, and mentor junior engineers...Senior
- Job Summary: Seeking a Senior Medical Device Quality & Compliance Engineer with expertise in Medical Device Quality Systems... .... Roles & Responsibilities: Lead design transfer and production support... ...and Preventive Actions (CAPA). Develop and maintain Risk Management...Senior
- Cepheid, a Danaher operating company, is seeking a Senior Quality Engineer to drive quality across manufacturing and new product introduction in Sunnyvale and Newark, CA. You will develop risk-based strategies and ensure compliance with ISO 13485 and 21 CFR 820 while enabling...Senior
- Intuitive Surgical seeks a Senior Human Factors Engineer for its Ion team. You will perform user-centered research, usability testing, and risk analyses to guide new and existing products. You will collaborate with designers, engineers, regulatory and clinical teams to...Senior
- A medical technology company in Sunnyvale, California is seeking a Senior Manufacturing Engineer to lead product/process development and manufacturing support in the medical devices sector. The ideal candidate will have a background in mechanical or biomedical engineering...Senior
- ...A tech-driven energy company based in Menlo Park is seeking a Quality Engineer to manage supplier quality. The role requires strong supplier relationship management and experience in quality engineering, especially in high-growth environments. Candidates should have a...SeniorRemote work
- Women Building Bio in Sunnyvale, CA is seeking a Senior Manufacturing Quality Engineer to advance TMV capabilities for catheter-based medical devices. You will work with the Manufacturing team to improve test methods, resolve defects, and drive yield, focusing on automating...Senior
- ...in Santa Clara, CA is seeking a hands-on engineer to develop procedures and BKMs for servicing... ...products. You will contribute to FMECA, lead Build & Test activities in the Apps lab,... ...on field issues, you will participate in CAPA and, if needed, failure analysis. You...Senior
- Intuitive Surgical, Inc. is seeking a Sr. Clinical Development Engineer on the Ion Endoluminal platform. The role collaborates with physicians and design teams to translate clinical needs into robust product solutions for flexible robotic catheter platforms, with emphasis...SeniorFlexible hours
- Abbott seeks a Principal Regulatory Affairs Specialist to provide regulatory leadership for endovascular medical devices in Santa Clara, CA or Temecula, CA. You will manage regulatory activities across U.S., EU, and other markets, supporting lifecycle management and global...Senior
$182.36k - $273.2k
...to thrive, learn, and lead. Your Team, Your ImpactMarvell... ...retimers, coherent DSP devices, and high-speed optical... ...a global, multi-site engineering organization spanning... ...we are looking for a senior experienced technical leader... ...engineering, and quality· Manage and communicate...SeniorPermanent employmentFull timeWork from home- ...working on-site in Santa Clara, CA or Temecula, CA. You will lead regulatory strategy, manage global submissions (FDA, EU MDR),... ...development through commercialization. The role requires 6-8 years in medical devices, experience with Class II/III devices, and strong...Senior
- ...a global leader in robotic-assisted surgery, seeks a Senior Regulatory Affairs Specialist to lead regulatory plans, assess design-change impacts, and prepare... ...and international markets. You will collaborate with engineering and manufacturing to ensure compliance with US FDA,...Senior
- Intuitive in Sunnyvale, CA seeks an experienced Regulatory Affairs professional to provide expert leadership in global submissions and compliance strategy. The role focuses on cross-functional coordination, technical documentation, and agency interactions to support product...SeniorWorldwide
- ...Affairs Specialist in Sunnyvale, CA. The role requires a BS degree and at least 8 years of Regulatory Affairs experience in medical devices. You will lead regulatory plans, prepare FDA 510(k) submissions, and guide product teams on US, Canada, and EU pathways. You will...Senior
$117.5k - $176.3k
Northrop Grumman Corp. (JP) is seeking a Sr. Principal Quality Analyst in Sunnyvale, CA. The role involves developing and maintaining PC-DMIS programs, leading investigations on nonconformances, and training metrology personnel. Candidates should have a Bachelor's Degree...Senior- ...Principal Regulatory Affairs Specialist to spearhead complex regulatory strategies for Class III devices. This role involves authoring PMA submissions, ensuring compliance for medical devices, and mentoring junior staff. Strong background in regulatory affairs and experience...Senior
- ...Technology in Santa Clara, CA seeks a QP(DCC, Customer Service, QS) Engineer to lead quality program management, document control, and customer quality... ...drive QMS compliance with ISO 9001, coordinate audits and CAPA actions, manage quality deliverables, track KPIs, and work...
$196k - $310.5k
...the world.NVIDIA Silicon Codesign Group is seeking a versatile engineer to join the HW bring-up methodology team. The SCG team is uniquely... ...logistics to support ambitious NPI and production schedules.Lead post-action reviews and convert learnings into concrete process...SeniorFull time- ...seasoned and highly collaborative Senior Quality Engineer to provide technical... ...Quality Management System (QMS), lead supplier and internal... ...Corrective and Preventive Action (CAPA). Lead cross-functional... ...coverage options for employee medical, dental, vision, and life...SeniorImmediate startFlexible hours
$169.8k - $355.4k
The Senior Director of Manufacturing Quality Engineering is a senior leadership role responsible for... ...potential at a company leading the way in AI and cloud... ...our people with flexible medical, life insurance, and retirement... .../preventive actions (CAPA) to address quality...SeniorTemporary workWork at officeFlexible hours- System One is seeking a Regulatory Affairs Specialist IV in Sunnyvale, CA, to lead regulatory strategy and submissions for medical devices across the U.S., Canada, and global markets. This 6‑month contract role requires deep regulatory expertise and strong cross‑functional...SeniorContract work
- Senior Quality Engineer (Finance) Company Description It started with a simple idea: what if surgery could... ...area. Essential Job Duties Leads critical product, process investigations... ...own corrective and preventive action (CAPA) and/or Process NCs Ownership of risk...SeniorWork at officeLocal areaWorldwideFlexible hours
- ...A startup technology company in Mountain View, CA is seeking a Senior/Staff Mechanical Engineer to advance their automation robotics system. The ideal candidate will have a degree in mechanical engineering and experience with Solidworks, as well as a hands-on attitude...Senior
- ...Summary:We are seeking an experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and... ...handling, post-market surveillance, CAPA, and regulatory compliance.This role... ....Roles & Responsibilities:Lead design transfer and production support...Senior
- ...Description:The mission of Supplier Engineering is to ensure high quality and stable delivery of... ...assessment by supporting lead auditors in QMS... ...Inertial Sensors, Resolvers)Medical Gas Line ProcessingProven... ...informationExperience in a medical device company is a...Senior
- ...level Controls Technician to design, develop, and lead the implementation of complex industrial... ...setting programming standards, mentoring junior engineers, and architecting scalable PLC, HMI, SCADA, and field-device solutions across projects. #J-18808-Ljbffr HKA...Senior
- ...worldwide.We’re a team of engineers, clinicians, and... ...Function of the PositionThe Senior Clinical Development... ...surgical environment and medical technology to work with... ...requirements to ensure a high-quality patient outcome.... ...experience in medical device industry with a Bachelor...SeniorLocal areaWorldwideFlexible hours
- ...worldwide.We’re a team of engineers, clinicians, and... ...the PositionThe Digital Senior Clinical Development Engineer... ..., regulatory, and quality teams to define... ...and emerging standards.Lead complex clinical development... ...of experience in medical device industry with a Bachelor...SeniorLocal areaWorldwideFlexible hours
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