Staff Quality Systems & Compliance Engineer
Core
Ensuring quality and compliance for robotic biologics manufacturing systems to enable scalable production of life-saving therapies.
Role type
Staff Quality Systems & Compliance Engineer
Builds
Automated biologics manufacturing robots and cloud-integrated hardware-software systems
Domain
Biomanufacturing / Robotics / Regulatory Compliance
Deliverable
production ML models
Required skills
Quality Systems, Regulatory Compliance, Biologics Manufacturing, Robotic Systems, GMP, FDA Regulations, Risk Management, Process Validation, Technical Documentation, Cross-functional Leadership
Preferred skills
Experience in biopharma automation, Knowledge of ISO 13485, Familiarity with AI/ML in manufacturing
Technologies
Cloud-integrated systems, Robotic orchestration platforms
Responsibilities
Develop and maintain quality management systems for robotic manufacturing equipment, Ensure compliance with FDA and GMP regulations for biologics production, Lead validation and verification activities for automated systems, Collaborate with engineering teams to integrate quality controls into robotic workflows, Audit manufacturing processes for regulatory adherence, Mentor junior quality engineers
Seniority
Staff, hands-on IC with strategic influence
