Senior Quality Engineer - Medical Devices, CAPA & CI
IRhythm Technologies Inc.
iRhythm Technologies Inc. in Cypress, CA, is hiring a Sr. Quality Engineer to provide on-site quality engineering support for high-volume medical device manufacturing, ensuring product quality and regulatory compliance. You will lead investigations for nonconformances, CAPA actions, change control, MRB activities, and data-driven quality improvements using SPC, Cp/Cpk, and risk management in a fast-paced environment. Experience in FDA-regulated settings and ISO 13485 is required. #J-18808-Ljbffr IRhythm Technologies Inc.
- ...Pharma in Los Angeles County, CA seeks a Senior Quality Engineer to design, implement, and maintain... ..., manufacturing, and testing of medical devices. The role is hybrid, with collaboration... ...assessments, root-cause analyses, and CAPA programs, review development deliverables...Senior
- Quasar San Diego LLC seeks a Staff Metrology & Quality Engineer to advance metrology in a regulated medical device setting. You will develop inspection systems, program... .... The role emphasizes quality investigations, CAPAs, and validation activities, with emphasis on GD&T...Senior
- Tandem Diabetes Care is hiring a Senior Quality Engineer to lead sustaining engineering, quality systems, and process improvements for our hardware... ...across the organization. You will support audits, NCRs, CAPAs, and cross-functional teams; work on-site five days a week at...SeniorWork at office
- Tandem Diabetes Care Inc. seeks a Senior Quality Engineer to provide quality guidance across product launches, sustaining engineering, and quality... ...compliance, analyze quality data, lead audits, and support CAPA investigations, NCRs, and Gage R&R, #J-18808-Ljbffr Tandem...Senior
- MiniMed in Northridge, California is seeking a Principal Quality Engineer to lead on-site manufacturing quality operations, drive validation... ..., and ensure regulatory compliance for next-generation medical devices. You will collaborate with cross-functional teams, develop...Senior
- Sonova is seeking a Senior Design Assurance Engineer to drive compliance for Software, Firmware and Hardware in Cochlear Implant tech. You’ll partner... ...standards. You’ll lead testing strategies, risk assessments, CAPA investigations and regulatory submissions, while mentoring...Senior
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- Real, a global medical technology innovator, is seeking two Senior Systems Engineers to bridge hardware, firmware, software, and IC development from concept to commercialization. The role requires hands-on embedded work and system-level thinking across multidisciplinary...SeniorRemote job
- MiniMed is seeking a Senior Mechanical Design Engineer for an on-site role in Northridge, CA. You will lead mechanical and electromechanical product development, verify and validate designs, and support transfer from R&D to manufacturing. Strong CAD/SolidWorks experience...Senior
- Katalyst CRO in Sacramento seeks a senior R&D leader to drive process development, characterization, and validation for medical device programs. You will design and execute DOE, TMV, IQ/OQ/PQ studies and apply statistical analysis to improve processes and products. The...Senior
- The Senior Quality Engineer is a hybrid role based in Los Angeles County, CA. This... ...Nervonik’s neuromodulation devices. Day-to-day activities... ...verification activities for complex medical devices. Experience with... ...Experience leading audits, managing CAPA programs, and using...Senior
- ...Scientific is seeking a Sr. Supplier QA Engineer to drive quality improvements for outside-sourced... ...protocol development, with emphasis on CAPA and supplier performance management.... ...a BS in engineering with 5+ years in medical devices or regulated industries, strong project...Senior
- We are seeking a Software Quality Engineer to support and oversee the software development life... ..., 1-2+ years of experience in medical device software Working knowledge of IEC 623... ...with quality management within software (CAPA, NCR) Familiarity with software risk...Senior
- Tandem Diabetes Care in the United States is seeking a Senior Quality Engineer to strengthen sterilization and quality systems across hardware development... ...regulatory compliance while guiding risk assessment and CAPA programs. You will collaborate with Manufacturing,...Senior
- RepliGen Corporation in Rancho Dominguez, CA seeks a Senior Quality Engineer to partner across Manufacturing, Engineering, Operations, Supply Chain... ...-quality biologics products. You will lead investigations, CAPA, and QA initiatives from concept through implementation. The...Senior
$115k - $155k
The Senior Quality Engineer is a key member of the Rancho Dominguez team, serving as a trusted quality... ...and manufacturing issues, initiate CAPA activities, and monitor the... ...filtration products, single-use technologies, medical devices, biologics, pharmaceutical...SeniorWork at officeWorldwideFlexible hours- ...before customers do, and give engineers the evidence they need to fix... ...where direct testing on real devices and careful human judgment remain... ...of what changed. Release quality Set release criteria,... ...Swift, Python, shell, XCTest, or CI experience. A record of building...SeniorRemote work
- Repligen Corp is seeking a Senior Quality Engineer for our Rancho Dominguez, CA site. You will partner with Manufacturing, Engineering, Operations... ...collaboration, with responsibilities spanning ISO audits, CAPA, and process enhancements to mitigate risk and improve customer...Senior
- NearSource Technologies is seeking a Senior DevOps Engineer to lead AWS deployments and build scalable cloud infrastructure. You will drive platform... ...accelerate delivery through automation. The role emphasizes CI/CD with Jenkins and GitHub Actions, Docker and Kubernetes,...SeniorRemote jobHourly pay
- ITMC Systems, Inc. is seeking a senior mechanical engineer with 8-12 years of experience in mechanical design and medical device NPD. You will lead electromechanical development across full product lifecycles in regulated environments, delivering robust, manufacturable...Senior
- ...Technician for Valencia, CA to execute system verification testing on implantable neuromodulation systems. You will work with R&D and engineering teams to configure test stations, analyze results, and maintain lab readiness. The role requires hands-on testing experience,...Senior
- ...tools used in product development, especially in a regulated medical device space. The tester will be a part of the Development Science functional... ...: Work closely with Development Science associates, Software engineers, and Panel Data subject matter experts and other testers to...Senior
- Metric Bio is recruiting a Principal Quality Engineer for its Northern California site. This on-site, full-time role offers... ...of quality activities across next-generation medical devices and direct exposure to senior leadership as the company expands its portfolio. You...Full time
$65 - $73 per hour
...delivers world-class end-to-end engineering solutions by leveraging our... ..., hi-tech, healthcare, medical devices, rail and semiconductor industries... .../Python). Integrate with CI/CD: Embed automated tests... ...development team and ensure quality is maintained with every release...SeniorFull timeTemporary work- ...Qualifications: BS degree in engineering, technology, or science from an accredited... ...software/hardware development projects in Quality Systems (Design Control) and Quality... ...Assurance (DHF Compliance) Experience in medical device or other regulated industries...SeniorLocal area
- ...About This Role: Position: Sr. Quality Engineer Reports to: Manager,... ...Cypress, CA About this role: The Senior Quality Engineer provides on... ...manufacturing operations of regulated medical devices. This role partners closely... ...regulatory expectations. CAPA Ownership Lead or support...Senior
- ...Description/Comment: Quality Design Assurance for Beckman Coulter Diagnostics is responsible for the support of Development QA functional core team members in the design and development of existing and new products from initiation through market release with an objective...Senior
$89.2k
Senior Quality Engineer - 18 Month Defined Term Onsite Location(s): Valencia, CA, US, 91355 Additional Location(s): N/A Diversity - Innovation... ...discipline. Minimum of 5 years' experience in the medical device or pharmaceutical industry. Strong understanding of regulatory...SeniorHourly payShift work$90k - $180k
## Senior Quality EngineerApply: United States - California - Sylmar: Full time: Posted Today... ...and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...developing and maintaining quality engineering methodologies and providing quality engineering...SeniorFull timeWork experience placementShift work- ...Job Title: Senior Test Automation Engineer Location: California Location: Rancho Cordova, California... ...Selenium, Playwright, Java/JavaScript, CI/CD, and SQL. Mandatory... ...of experience in software testing and quality engineering, including test strategy,...Senior
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