Quality Systems Lead for MedTech Startup

Lumicity; San Francisco (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Lumicity is seeking a Quality Systems Lead to build and scale the quality infrastructure for an early-stage medical device company. This hands-on role requires implementing and operationalizing QMS and design controls in a fast-paced environment.

You will work cross-functionally with Engineering, Regulatory, Clinical, Operations, and Leadership to establish quality systems that enable rapid product development while maintaining regulatory compliance with 21 CFR 820 and ISO 13485.

Qualifications

• Hands-on experience implementing or building a medical device QMS.
• Strong knowledge of FDA QSR 21 CFR 820 and ISO 13485.
• Experience with design controls and risk management per ISO 14971.

Responsibilities

• Lead the design, implementation, and continuous improvement of the QMS.
• Establish scalable processes for document control, CAPA, NCRs, training, and audits.
• Support FDA 510(k) submissions and regulatory documentation.
• Partner with Engineering and Product Development to integrate quality requirements.
• Prepare for regulatory inspections and third-party audits.

Skills

QMS leadership

Regulatory compliance

Design controls

Cross-functional leadership

Documentation control

CAPA

Internal audits

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Audit management software

CAPA software

eQMS platforms

Job description

Lumicity is seeking a Quality Systems Lead to build and scale the quality infrastructure for an early-stage medical device company. This hands-on role requires implementing and operationalizing QMS and design controls in a fast-paced environment.

You will work cross-functionally with Engineering, Regulatory, Clinical, Operations, and Leadership to establish quality systems that enable rapid product development while maintaining regulatory compliance with 21 CFR 820 and ISO 13485.