- Gilead Sciences, Inc. (Foster City, CA)
- …development from early development to commercial launch, filing experience with FDA /EMA, and in-depth technology understanding for biological products are the key ... comprehensive control strategies for biologics products. + Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning… more
- US Tech Solutions (San Bruno, CA)
- …and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices ... Design History Files (DHF) including development plans, verification and validation plans, requirements specifications, and risk management files. **Risk Management… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and processes to ensure high quality products and compliance with EU & FDA current Good Distribution Practice (GDP) and National Association of Boards of Pharmacies ... Service personnel as well as Trade Operations, Regulatory Affairs and Validation /Packaging Engineering. + Interfaces with and provides QA oversight of contracted… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies, including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Primary Duties and Responsibilities: + ... in the development and maintenance of clinical trials management systems including validation of systems. + Prepares project reports and performs basic statistical… more
- J&J Family of Companies (Santa Clara, CA)
- …in full compliance with the company's Design Control requirements and consistent with FDA , ISO, and MDD/MDR requirements + Prototype and develop proof of concept ... and perform product in-vitro, in-vivo as well as verification and validation testing + Perform process-related design tasks to support transitioning designs… more
- Caldera Medical (Westlake Village, CA)
- …quality, distribution, and commercial support. * Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDD/MDR, MDSAP, and other international regulations. ... (NPD), including design control, risk management, reliability engineering, and validation . * Manage Quality oversight for multi-site manufacturing and contract… more
- Abbott (Alameda, CA)
- …addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control ... lifecycle development processes that are consistent with ISO, IEEE, or other FDA recognized standards. + Knowledge of design controls and regulations for medical… more
- Sutter Health (Berkeley, CA)
- …and oversight of equipment maintenance. Individual is responsible for the validation , development and/or implementation of new procedure, policies, equipment and ... the blood bank. The BB Lead maintains the lab registrations with ICBBA and FDA , and participates in renewal process of laboratory Biologics license. The BB Lead CLS… more
- Globus Medical, Inc. (San Diego, CA)
- …design specifications for new product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project + Manage of all ... vendors for rapid prototyping and evaluation. + Perform design verification and validation activities to ensure designs meet specifications + Partner with marketing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …engineering on new combination product development, supporting design verification, validation , and transfer activities. + Contribute to quality improvement ... initiatives and ensure compliance with relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part4, ISO 13485, ISO 14971, and Gilead's quality… more