- TechDigital Group (Foster City, CA)
- …service excellence Knowledge in Life science domain and GxP principles. Responsibilities: Perform onsite QMS lead role and work with business team and ... QMS configuration is required. Ability to perform Consultant role as per GVault Requirements. Work closely with Business...on high level design and coordinate with Offshore Tech Lead and finalize the design. Work with Offshore Tech… more
- Quality Metal Spinning and Machining (Palo Alto, CA)
- …Comprehensive benefits package Clear opportunity for growth into a senior Quality Engineer role About QMS Quality Metal Spinning & Machining ( QMS ) ... Semiconductor Manufacturing Location Palo Alto, CA Company Quality Metal Spinning & Machining ( QMS ) Position Summary Quality Metal Spinning & Machining ( QMS ) is… more
- Until (San Francisco, CA)
- …is both strategic and hands-on . You will design and implement a fit-for-purpose QMS , define regulatory pathways, lead agency interactions, and act as the ... Key Responsibilities Design, implement, and maintain a scalable Quality Management System ( QMS ) aligned with: FDA (21 CFR 820, 21 CFR 210/211 as applicable),… more
- Taara Connect, Inc. (Sunnyvale, CA)
- …way we use light to deliver faster, cheaper, more reliable connectivity. Lead the charge in bringing our groundbreaking wireless optical communication and photonics ... the way for bridging the digital divide and illuminating the future. About the Role : Taara is seeking an Hardware Module NPI Operations Program Manager to own our… more
- BridgeBio Pharma (San Francisco, CA)
- …and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and ... for multiple clinical studies through all stages of clinical development. The role will also have responsibility for global end‑to‑end commercial supply chain… more
- Penumbra, Inc. (Alameda, CA)
- …considered, however, the candidate must reside within the region while in the role . Relocation expenditures will not be provided. What You'll Work On Customer ... as needed Adhere to the Company's Quality Management System ( QMS ) as well as domestic and global quality system...up to 50%. Ability to wear 7-9 pounds of lead for extended periods of time. Occasional on-call availability… more
- El Camino Health (San Francisco, CA)
- …quality, compliance, and continuous improvement while maintaining business continuity. In this role , you will have the opportunity to lead cross-functional ... the future of cardiac health, our company, and your career**About This Role :**iRhythm's Product Development team is seeking a highly skilled Senior Project Engineer… more
- Revolution Medicines (Redwood City, CA)
- …and vendors to integrate RIM with other enterprise systems (eg, eTMF, CTMS, QMS ) and ensure seamless workflows. Lead RIM release management, communicate system ... Senior Director and Head of Regulatory Operations and Planning to build, lead , and scale Revolution Medicines' regulatory information management capabilities. This … more
- Gilead Sciences, Inc. (Foster City, CA)
- …to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are ... for the qualifications and skills we seek for this role . US Education & Experience BA/BS with 8+ years'...of quality and/or compliance activities, including authoring SOPs, leading QMS projects, and training others on quality and/or compliance… more
- Cedent Consulting Inc. (Pleasanton, CA)
- Manager/Director Regulatory Affairs - Pleasanton, CA In This Role , You Will Develop and implement regulatory strategies to obtain FDA clearances, approvals, and ... compliance for new and existing medical devices. Lead the preparation, submission, and maintenance of regulatory filings such as 510ks, letters to file, and… more
