- Antech Diagnostics (Fountain Valley, CA)
- …on emerging security threats, vulnerabilities and mitigation techniques. **Product Security Validation :** + Organize and support the product security review process ... delivery and required level of quality in all aspects of the validation process. + Provide Standardized product security documentation. + Collaborate with other… more
- Capgemini (Sylmar, CA)
- …with ISA-95 architecture and manufacturing data standards. + Experience with system validation and electronic records/electronic signatures (ER/ES). + Knowledge ... + Collaborate with cross-functional teams including manufacturing, quality, and IT. + Ensure system compliance with FDA , ISO 13485, and GxP standards. +… more
- Actalent (Irvine, CA)
- …responsible for ensuring compliance with internal and external regulatory requirements, including FDA , ISO, and MDD standards. You will play a pivotal role in ... developing an optimal Quality Management System (QMS) that meets business needs and supports new...development lifecycle, including risk management and design/process verification and validation . + Applied knowledge of Advanced Quality tools such… more
- IQVIA (Valencia, CA)
- …intermediate technical expertise to develop, maintain, and test Laboratory Data Management systems and data extraction tools to support clinical trial workflows and ... Test clinical study databases in alignment with programming standards and validation procedures + Contribute solutions and insights independently to development and… more
- Terumo Neuro (Aliso Viejo, CA)
- …and spatial packaging of components. 7. Working knowledge of medical devices and FDA regulations. 8. Experience with CAPA systems , including complaint handling. ... + Work in cross-functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings to meet these needs. + Ability… more
- Sutter Health (Santa Rosa, CA)
- …including policy and procedure and workflow development. + Identifies new systems , processes, protocols and/or methods to improve practices. + Actively contributes ... policies and department standards. + Completes all annual competency validation requirements. + Participates in quality improvement processes, including updating… more
- Abbott (Alameda, CA)
- …addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control ... determine appropriate action. **Required Qualifications** + Bachelor of Science in Computer Science, Engineering Mathematics, or related field. MS desired. + Minimum… more
- Abbott (Sylmar, CA)
- …quality engineering support within new product development, manufacturing, or system /services support. This position is responsible for developing and maintaining ... support within new product design and development, manufacturing, or system /services support. **MAIN RESPONSIBILITIES** + Identify and implement effective methods… more
- Philips (San Diego, CA)
- …projects (SaMD) as well as software-related aspects of complex medical systems (SiMD). Manages the development, oversight and execution of comprehensive software ... internal policies throughout the software lifecycle. + Authorizes/Leads the assessment, validation and approvals of software designs/inputs, overseeing the review of… more
- Abbott (Sylmar, CA)
- …software. You'll work closely with developers, QA, and regulatory teams to ensure our systems are fast, reliable, and compliant with FDA and ISO standards. ... our workflows more efficient and reliable. + Monitor and support production systems , ensuring they're running smoothly and safely. + Troubleshoot and resolve issues… more