- Philips (San Diego, CA)
- …tools, and innovative methodologies to continuously enhance software quality and regulatory compliance . + Will oversee the development, maintenance, and ... You have a minimum of 8+ years' experience in FDA regulated, IEC 62304 medical device software environments (SiMD/SaMD), with a focus on Software Design… more
- Cedars-Sinai (Los Angeles, CA)
- …will be involved in the development and possible commercialization of a novel medical device technology. Interest or experience in a start-up environment with ... will assist in the effort in validating the clinical trial of groundbreaking medical imaging systems. The job will provide an outstanding opportunity to work with… more
- Hologic (San Diego, CA)
- …Supplier Quality Sr. Director/Director that may affect product quality or regulatory compliance . + **Interdepartmental Collaboration:** Work with other Global ... auditing program, ensuring that our suppliers adhere to rigorous regulatory and quality standards. You will lead and guide...roles + Clean driver's license + Proficient knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation,… more
- Stryker (Irvine, CA)
- …venous and other vascular diseases through purpose-driven innovation. As a fast-growing medical device company, we develop breakthrough technologies that treat ... Staff R&D Engineer supports and leads project teams in the development of medical device products - this includes writing or verifying specifications, developing… more
- Veterans Affairs, Veterans Health Administration (Palo Alto, CA)
- …Veterans Integrated Services Network Advisory Board, Clinical Product Review, Reusable Medical Device , Environment of Care Rounds, and Enterprise Equipment ... outcomes. Provides health system-wide leadership for critical and semi-critical Reusable Medical Device (RDM), including sterile storage, reprocessing, standard… more
- NTT America, Inc. (Sacramento, CA)
- …a global scale, including knowledge of international taxation, foreign exchange, and regulatory compliance in multiple regions. KEY RESPONSIBILITIES + Develops ... a global scale, including knowledge of international taxation, foreign exchange, and regulatory compliance in multiple regions. + Experience in transforming… more
- Abbott (Temecula, CA)
- …writing skills. **Preferred Qualifications** + Masters Degree Preferred + Prior medical device experience preferred. ASQ CQE certification preferred. Design ... method validation activities + Ensure DHF content completion, integrity, and regulatory & standards compliance ; collaboratively communicating & resolving gaps… more
- Terumo Neuro (Aliso Viejo, CA)
- …minimum of eight (8) years of professional experience in a manufacturing setting within the medical device industry or similar field. 3. A minimum of two (2) ... large production team to achieve key goals for safety, compliance , and output. Job duties: + Direct a team...to analyze data/metrics and propose solutions. 4. Knowledge of medical device production equipment. 5. Experience with… more
- Envista Holdings Corporation (Thousand Oaks, CA)
- …targets and expectations. + 3 years' experience leading operations within a dental device or medical device (FDA regulated industry) environment strongly ... all KPIs, inventory and budget targets + Adhere to and meet all regulatory requirements + Coach, lead and create a culture of continuous improvement utilizing… more
- Danaher Corporation (Sunnyvale, CA)
- …Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) ... position reports to the Senior Manager Quality Systems - Compliance and is part of the Quality Systems department...also possess previous experience in: + ISO 9001:2015 + Regulatory Intelligence Cepheid, a Danaher operating company, offers a… more