- Stryker (Irvine, CA)
- …**Preferred:** + MS, CQE, or CRE. + Six Sigma Green or Black belt. + Medical device industry experience is strongly preferred. + Experience in interacting with ... performance across the business and for customers while ensuring regulatory standards and compliance . **What You Will...MoH, TUV, etc.). + Understanding of US and International Medical Device Regulations. + Familiarity with ISO… more
- Walmart (Sunnyvale, CA)
- …Media or CTA‑WAVE groups. + Familiarity with continuous localization (i18n/L10n) and regulatory compliance (GDPR/CCPA, energy consumption). At Walmart, we offer ... and interactive overlays. + Automate CI/CD: containerized build farms, device ‑cloud testing (Bitrise, BrowserStack, LambdaTest), firmware signing, and phased… more
- GE HealthCare (CA)
- …field. + Minimum 5-8 years of technical project management experience in healthcare software or medical device R&D, with a focus on AI or software integration. + ... resources, and escalate constraints or risks with mitigation strategies. + Ensure regulatory and compliance requirements are met throughout integration. +… more
- Abbott (Temecula, CA)
- …serve people in more than 160 countries. **About Abbott** For years, Abbott's medical device businesses have offered technologies that are faster, more ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...findings. + Ensures sustaining support of Quality System and regulatory compliance by individually working quality system… more
- GRAIL (Menlo Park, CA)
- …experience in managing clinical trials at a sponsor company (pharma, biotech, or medical device ) with a strong track record of successful trial initiation ... experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable + Thorough knowledge of… more
- Astrix Technology (Irvine, CA)
- …+ Knowledge of FDA regulations (21 CFR 820/803), ISO 13485 + Experience with medical device complaint handling and regulatory reporting (MDR, Vigilance, ... work for a global leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses in Surgical and Vision… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …devices marketed in all regions throughout the world. + Expertise in failure investigation and medical device CAPA process. + Experience in medical device ... responsible for the San Diego Design Center Quality Systems, Compliance , and for ensuring consistent application of Design Controls...of possible** BD is one of the largest global medical technology companies in the world. Advancing the world… more
- Abbott (Sylmar, CA)
- …diverse and growing portfolio of digital health products, including software as a medical device (SaMD), connected devices, and digital health platforms. This ... the global QA strategy for Digital Solutions + Ensure compliance with all applicable standards and regulations (eg, FDA...years of progressive experience in Quality Assurance within the medical device or digital health industry +… more
- Stryker (San Jose, CA)
- …Provide guidance on cleaning, disinfection, sterilization, and biocompatibility for reusable medical device design. + Develop, review, and approve sterilization ... microbiological or biological testing, R&D, or sterility assurance within the medical device , pharmaceutical or regulated industry. Preferred Qualifications: +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Cross-Functional Collaboration:Establish and model effective engagement pathways between Quality, Device Engineering, Regulatory , and internal and external ... knowledge and experience in quality assurance for the development of medical devices and/or drug- device combination products. **Preferred Qualifications:** +… more