Laboratory Operations & Compliance Lead

Lumicity; San Francisco (CA); On-site; USD 150,000 - 180,000; Full time

Job summary

Lumicity is seeking a hands-on Lab Operations Lead to oversee daily lab activities across engineering and R&D labs. You will optimize workflows, ensure compliance with FDA QSR and ISO 13485, and manage equipment and safety programs while partnering with Quality, Regulatory Affairs, Manufacturing and Facilities.

The ideal candidate will bring 5+ years in regulated lab management, strong project management, and the ability to mentor staff in a fast-paced environment focused on product development

Qualifications

• Bachelor's degree in engineering, biology, chemistry, biomedical engineering, life sciences or a related technical discipline.
• At least 5 years in laboratory operations or management in regulated environments (medical device, biotech or pharma).
• Knowledge of FDA QSR (21 CFR Part 820), ISO 13485 and GDP; strong documentation practices.

Responsibilities

• Lead daily lab operations, ensure organization, readiness, and efficiency.
• Develop and improve SOPs, workflows, and scheduling across projects.
• Manage equipment lifecycle, calibration, maintenance, and vendor relations.
• Maintain safety, quality, and regulatory compliance under OSHA and GDP requirements.
• Coordinate inventory, consumables, and supply chain; monitor budgets.
• Collaborate with R&D, Product Development, Manufacturing, Quality, and Regulatory teams.
• Mentor staff and drive safety, accountability, and continuous improvement.

Skills

Leadership

Lab Management

Regulatory Compliance

Project Management

Cross-functional Collaboration

Vendor Management

Education

Bachelor's degree in STEM

Tools

LIMS

eQMS

Job description

Lumicity is seeking a hands-on Lab Operations Lead to oversee daily lab activities across engineering and R&D labs. You will optimize workflows, ensure compliance with FDA QSR and ISO 13485, and manage equipment and safety programs while partnering with Quality, Regulatory Affairs, Manufacturing and Facilities.

The ideal candidate will bring 5+ years in regulated lab management, strong project management, and the ability to mentor staff in a fast-paced environment focused on product development