21-cfr-part-820 jobs in San Diego

Senior Automation Engineer supporting the development, maintenance, and operation of complex custom automation systems in a biotech environment. Responsibilities include understanding system requirements, developing scripted protocols, supporting system integration across hardware and software, troubleshooting failures, and ensuring compliance with FDA regulations and GxP principles.…See more The role requires proficiency in C#, experience with robotics, motion control, machine vision, and strong problem-solving skills to maintain system uptime in a regulated biotech setting.

Senior Automation Engineer responsible for developing, maintaining, and operating complex custom automation systems in a biotech stem-cell therapy environment. The role requires designing scripted protocols, integrating hardware and software components, troubleshooting system failures, and ensuring compliance with FDA regulations and GxP principles.…See more Requires 5+ years in hardware design, automation, or biotech; proficiency in C#; and hands-on experience with robotics, motion control, sensors, and machine vision systems.

The Senior Automation Engineer will develop, maintain, and troubleshoot complex custom automation systems for biotech applications, with a focus on hardware–software integration and regulatory compliance. Responsibilities include writing operational protocols, performing system integration, conducting verification and validation testing, and collaborating across cross-functional teams.…See more The role requires a strong foundation in automation engineering principles, C# proficiency, hands-on experience with robotics, motion control, sensors, and machine vision, plus familiarity with FDA regulations (21 CFR Parts 11, 210, 211, 820) and GxP principles.

Sr. Director of Software Quality will build and lead Illumina's standalone Software Quality organization, establishing governance frameworks aligned with IEC 62304, ISO 13485, ISO 14971, and emerging AI Act requirements.…See more The role owns the Software Quality Management System across all software products, software-driven IVDs, and AI/ML-enabled diagnostics, embedding quality checkpoints throughout the product development lifecycle and post-market surveillance. Responsibilities include recruiting and developing a high-performing team, defining verification and validation standards, managing regulatory compliance for FDA, EU MDR/IVDR, and other global bodies, and serving as the subject-matter expert in regulatory inspections. The candidate must have deep hands-on expertise in IEC 62304, SaMD classification frameworks, cybersecurity in QMS (IEC 81001-5-1), and demonstrated experience building and leading software quality functions in regulated medical device environments.

Quality Assurance Specialist II leads and supports audit activities, serves as a QA subject matter expert during inspections, and manages quality events and risk assessments for medical device products. The role involves conducting root cause analyses, managing document control and training workflows, coordinating the internal audit program, and driving quality-system improvement projects.…See more The position requires a bachelor's degree in a scientific or engineering discipline with 3–5 years of QA or regulatory affairs experience in a regulated industry, with medical device experience highly preferred. Key responsibilities include compliance with ISO 13485 and 21 CFR Part 820, partnership with senior quality engineers on risk management, and eQMS implementation and validation.

Senior Automation Engineer supporting development, maintenance, and operation of complex custom automation systems in a biotech environment. Responsibilities include understanding system requirements, developing scripted protocols, integrating hardware and software components, troubleshooting failures, and ensuring compliance with FDA regulations and GxP principles.…See more Requires 5+ years in hardware design, automation, or biotech, with proficiency in C#, robotics, motion control, machine vision, and electronic systems integration.

Senior Automation Engineer at a biotech firm developing autologous stem-cell therapies. Responsible for developing, maintaining, and troubleshooting complex custom automation systems, including scripted protocols, hardware-software integration, and verification/validation testing.…See more Requires 5+ years in hardware design, automation, or biotech, with strong C# software integration skills, robotics and motion control expertise, and knowledge of FDA regulations (21 CFR 11, 210, 211, 820) and GxP principles.

The Senior Automation Engineer will develop, maintain, and troubleshoot complex custom automation systems in a biotech setting, working with hardware (robotics, motion platforms, sensors, machine vision) and software (C# codebases). Responsibilities include creating operational protocols, supporting system integration, developing verification and validation plans, and ensuring compliance with FDA regulations (21 CFR Parts 11, 210, 211, 820) and GxP principles.…See more The role requires 5+ years in hardware design, automation, or biotechnology, with strong problem-solving skills and the ability to collaborate across cross-functional teams.