- Abbott (Alameda, CA)
- …current Quality System Requirements. + Works independently with objectives given by SWQA Manager . + Can plan and coordinate own work according to higher-level ... project schedules. + Reviews and provides lead guidance to...of departmental operating procedures to ensure compliance to relevant FDA , QSR, ISO guidelines, including 21 CFR Part 11… more
- Abbott (Alameda, CA)
- …**What You'll Work On** + Participates as a member of the project team for Lingo products that incorporate software/firmware into their system. + ... current Quality System Requirements. + Works independently with objectives given by SWQA Manager . + Can plan and coordinate own work according to higher-level … more
- Stanford Health Care (Palo Alto, CA)
- …Ensures organizational compliance with federal/state regulations and accreditation requirements ( FDA , CDPH, BOP, TJC, etc.) for medication management. Develops audit ... managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, sample medications, investigational studies,… more
- Meta (Burlingame, CA)
- …Medical Devices, Regulatory Specialist Responsibilities: 1. Interact directly with FDA and/or indirectly with international regulatory agencies on most ... reviewer level. All significant issues will be reviewed with the manager 2. Support regulatory compliance activities, including site registration, audits,… more
- Envista Holdings Corporation (Pomona, CA)
- …Sr. Quality Engineer will report directly to the Quality Engineering Manager . **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Actively participates in defining customer ... and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards....execution of projects (ie Problem-Solving Process (PSP) and Visual Project Management (VPM)). + Any duties or tasks assigned… more
- Fujifilm (Sacramento, CA)
- …on systems within a service area as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Niagara Bottling LLC (Diamond Bar, CA)
- …for the batching and process system. + Collaborate with vendors, corporate project managers and operations to support beverage equipment installation and ensure ... successful commissioning. + Experience working with process authorities and FDA related certification and validations + Work with appropriate cross functional teams… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Senior Director, Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as ... **KEY RESPONSIBILITIES** Reporting to the Executive Director of Product & Project Management and operating within the broader Pharmaceutical Development and… more
- Amgen (Thousand Oaks, CA)
- …Product Technologies organization. Working with the Principal Engineer Process Validation Manager of Amgen Thousand Oaks (ATO) Process Engineering, this role will ... that the site meets the quality requirements of its customers and applicable regulations ( FDA , EU & global standards). + Assist in the development of any existing… more
- AbbVie (Pleasanton, CA)
- …+ Manage the overall development of parts and subassemblies for a project design. Interact with Clinical and Marketing departments to determine design requirements ... and goals. + Outline and execute to short-term goals to achieve overall project milestones. + Conceive, design, build, and evaluate prototypes to explore a range of… more