- Antech Diagnostics (Fountain Valley, CA)
- …on emerging security threats, vulnerabilities and mitigation techniques. **Product Security Validation :** + Organize and support the product security review process ... required level of quality in all aspects of the validation process. + Provide Standardized product security documentation. +...are a plus. + Experience working in a regulated ( FDA , MDR) environment with medical instrumentation is a plus.… more
- Abbott (Alameda, CA)
- …processes to perform impact assessments for new product introduction and process validation + Manage bill of materials for all levels of product assembly ... principles. + Extensive Knowledge of regulations for medical device development (ISO13485, FDA ) is a plus. Extensive understanding of processes and materials used in… 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 Part 4, ISO 13485, ISO 14971, and Gilead's quality… more
- Abbott (Sylmar, CA)
- …tasks within a larger effort such as user need and feature definition, validation or product development of a sub-system, and drives them to on-time, high ... protocols, data analysis, and reports + Contributes to the evaluation and validation of a specific subsystem or project as necessary to conduct feasibility… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …and technical QA staff. * Deep knowledge of global medical device regulations ( FDA , EU MDR, etc.). * ASQ certification (Engineer or Manager) preferred. * Six ... Controls + Change Control + Risk Management + Process Validation + Non-conformance and deviation handling + Test Method... + Non-conformance and deviation handling + Test Method Validation + Supplier Qualification + Post-Market Surveillance + CAPA… more
- ManpowerGroup (Fremont, CA)
- …issues and implement process improvements. + Conduct product and process validation , and review associated documentation. + Investigate non-conformances, lead CAPA ... quality assurance experience. + In-depth knowledge of quality management systems (ISO, FDA , IVDR, QSR). + Proven experience in product and process validation… more
- Actalent (Valencia, CA)
- …improvement of development processes and tools. + Support verification, validation , and regulatory documentation activities as required. Essential Skills + ... as medical devices, aerospace, or automotive. + Familiarity with IEC, FDA premarket cybersecurity guidance, or other relevant software lifecycle and cybersecurity… more
- Abbott (Milpitas, CA)
- …and ensures compliance with company policies and procedures (eg compliance with FDA regulations, etc.) + *Makes and executes operational decisions with a strategic ... requirements development, user interface design, user error analysis, usability and validation testing. + Extensive knowledge of entire medical device development… more
- Edwards Lifesciences (Irvine, CA)
- …leading to manufacturing efficiency improvement + Knowledge of cGMP, EHS guidelines, FDA guidelines, QSR, FMEA, statistical techniques, Supplier Quality and Process ... Validation (IQ, OQ, PQ and PPQ) + Interpersonal skills including problem solving, effective communication, conflict and relationship management + Solid project… more
- AbbVie (Irvine, CA)
- …Specific areas of support may include the Document Center, Device QA, Labeling, Validation , Training and CAPA. This position will ensure that all product, process or ... system. May be required to prepare and present data during regulatory audits ( FDA , EMA, Anvisa, etc) and internal audits. *Interact with internal and external… more