- Fujifilm (Sacramento, CA)
- …work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent in ... and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and… more
- Imperative Care (Campbell, CA)
- …project team to ensure products are designed, developed, and manufactured in compliance with customer needs, company quality systems, budget, schedule and regulatory ... quality systems designed to meet governmental regulations such as FDA, GMPs, QSR, ISO 13485/9001, and the MDD. + Experience leading a technical cross-functional team… more
- CDM Smith (Rancho Cucamonga, CA)
- …in a timely manner. - Ensuring your team members complete all required training ( Compliance , Health & Safety, Ethics, etc.) on time. - Ensuring your team members are ... project manuals. **Job Title:** Regional Team Leader, Specifications **Group:** ISO **Employment Type:** Regular **Minimum Qualifications:** - Bachelor's degree. -… more
- CDM Smith (Rancho Cucamonga, CA)
- …complexity as necessary to meet client requirements. Review draft designs for compliance with federal, state, and local regulations. Ensure that firm policies and ... **Job Title:** Management Specialist 6- Geothermal Discipline Leader **Group:** ISO **Employment Type:** Regular **Minimum Qualifications:** - Bachelor's degree. -… more
- Ankura (CA)
- …scoping calls, proposal writing, and pre-engagement discussions. + Support security strategy, compliance efforts (PCI DSS, HIPAA, ISO 27001, etc.), and security ... roadmap development. Requirements: + 5-8 years of experience in penetration testing, focusing on web applications, APIs, and mobile apps. + Proficiency with tools such as Burp Suite Pro, Postman, OWASP ZAP, MobSF, APKTool, Frida, Objection, and related tools.… more
- ZOLL Medical Corporation (San Jose, CA)
- …procedures to manufacture electromechanical and catheter-based medical devices in full compliance with the company's quality system. Apply Lean concepts to reduce ... electromechanical and/or catheter-based products (preferred). + Lean methodologies, FDA, ISO . Knowledge, Skills and Abilities + Solid background in mechanical,… more
- IQVIA (Valencia, CA)
- …project teams to organize timelines, responsibilities, and deliverables + Uphold compliance with SOPs, regulatory guidelines, and Good Clinical Practice standards ... in laboratory terminology and regulatory standards including FDA, GLP, ICH, ISO HL7 + Excellent problem-solving and communication skills with a customer-focused… more
- Abbott (San Diego, CA)
- …the design, development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in software design, ... a plus + Understanding of quality software engineering principles aligned with ISO , IEEE, or FDA-recognized standards is a plus **Preferred Qualifications** +… more
- Abbott (Alameda, CA)
- …projects aimed to optimize internal operations and adhere to evolving global compliance standards. This person will be responsible for project leadership of IT ... knowledge of regulations and standards related to medical devices (eg FDA, ISO , QSR design controls). + Experience Web applications or App Development… more
- Abbott (Santa Clara, CA)
- …manner. + Perform audits of manufacturing records during assembly to ensure compliance . + Perform final manufacturing Device History Record (DHR) and Lot History ... contractors, and vendors. + Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulator + requirements. + Multitasks, prioritizes… more