Lead Quality Engineer

Lumicity; San Francisco (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Lumicity in San Francisco is seeking a hands-on Lead Quality Engineer to own and improve the Quality Management System, and to support product development, V&V, manufacturing transfer, and production in a fast-paced startup environment.

The role demands 7+ years of quality engineering experience in FDA-regulated devices, with strong knowledge of 21 CFR Part 820, ISO 13485, and Design Controls. Collaboration with engineering, manufacturing, and regulatory teams is essential.

Qualifications

• 7+ years of Quality Engineering experience in FDA-regulated medical devices.
• Strong knowledge of 21 CFR Part 820, ISO 13485, and Design Controls.
• Experience supporting products from development through V&V and manufacturing transfer.
• Experience with ISO 14971, FMEA, CAPA, NCRs, and root-cause investigations.
• Strong technical documentation and problem-solving skills.
• Experience with suppliers and contract manufacturers.
• Comfortable working in a startup/fast-paced environment.

Responsibilities

• Own and improve the Quality Management System.
• Support design controls, risk management, change control, and design reviews.
• Lead CAPA, nonconformance, and root-cause investigations.
• Support verification, validation, process validation, and manufacturing transfer.
• Develop inspection procedures and quality processes.
• Support supplier quality and audits.
• Analyze quality data and drive continuous improvement.
• Ensure compliance with applicable FDA and ISO requirements.

Skills

Quality engineering experience

Regulatory knowledge

Product lifecycle

Quality tools: FMEA/CAPA

Technical documentation

Supplier quality

Startup environment

Education

Bachelor’s degree in Engineering or related field

Job description

My client is a growing medical device company developing technology designed to improve patient outcomes in acute-care settings.

They are seeking a hands-on Lead Quality Engineer to own and improve the Quality Management System while supporting product development, V&V, manufacturing transfer, and production.

This is a full-time, on-site role working closely with engineering, manufacturing, operations, and regulatory teams.

Qualifications

• Bachelor’s degree in Engineering or related technical field
• 7+ years of Quality Engineering experience within FDA-regulated medical devices
• Strong knowledge of 21 CFR Part 820, ISO 13485, and Design Controls
• Experience supporting products from development through V&V and manufacturing transfer
• Experience with ISO 14971, FMEA, CAPA, NCRs, and root-cause investigations
• Strong technical documentation and problem-solving skills
• Experience with suppliers and contract manufacturers
• Comfortable working in a startup/fast-paced environment

Key Responsibilities

• Own and improve the Quality Management System
• Support design controls, risk management, change control, and design reviews
• Lead CAPA, nonconformance, and root-cause investigations
• Support verification, validation, process validation, and manufacturing transfer
• Develop inspection procedures and quality processes
• Support supplier quality and audits
• Analyze quality data and drive continuous improvement
• Ensure compliance with applicable FDA and ISO requirements

Preferred

• Point-of-care, IVD, or laboratory instrumentation experience
• FDA 510(k) or audit experience
• Manufacturing process validation
• eQMS experience
• ASQ CQE or Six Sigma certification