Director of Quality

Lumicity; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Lumicity seeks a senior Quality Leader to own the QMS end-to-end, design controls, and build a scalable quality organization in San Francisco. You will drive regulatory readiness from early 510(k) work toward future PMA/combo-product pathways, while embedding quality in R&D and product teams.

You will establish an audit program, author SOPs, and lead post-market activities like CAPA and complaint handling, shaping the culture of quality across the company.

Qualifications

• Significant medical device quality experience is required.
• Deep working knowledge of ISO 13485, 21 CFR 820 / QMSR, and ISO 14971.
• Proven ownership of a Quality Management System, ideally including building or substantially standing one up.
• Experience leading internal, external, and supplier audits, and hosting regulatory or notified body audits.
• A track record authoring SOPs and driving real adherence across an organization.
• Post‑market quality experience, including CAPA and complaint handling.
• Experience supporting regulatory submissions, including 510(k) and PMA.

Responsibilities

• Own the Quality Management System end to end, including design, implementation, and continuous improvement.
• Oversee design controls across the product development lifecycle.
• Build, hire, and lead the quality team as the function grows.
• Lead the audit program across internal, external, and supplier audits, including regulatory bodies.
• Author, roll out, and maintain SOPs and drive adherence across the organization.
• Train and coach teams on quality, compliance, and the QMS.
• Stand up and lead post-market quality, including CAPA and complaint handling.
• Support the full regulatory arc from 510(k) toward PMA and combination-product pathways.
• Partner with R&D, engineering, operations, and leadership so quality is built-in, not a bottleneck.

Skills

QMS ownership

ISO 13485

21 CFR 820

Regulatory submissions

CAPA & complaints

Audit programs

SOP development

Cross-functional lead

Post-market quality

Team leadership

Job description

• Own the Quality Management System end to end, including its design, implementation, and continuous improvement, built to ISO 13485, 21 CFR 820 / QMSR, and ISO 14971, and scaled appropriately to the company's stage.
• Implement and oversee design controls across the product development lifecycle.
• Build, hire, and lead the quality team as the function grows, and define its structure over time.
• Lead the audit program across internal, external, and supplier audits, including hosting regulatory and notified body audits as the company matures.
• Author, roll out, and maintain SOPs, and build the practices and culture that keep the organization genuinely working to them.
• Train and coach teams on quality, compliance, and the QMS so that good practice is understood and owned across functions, not just enforced.
• Stand up and lead post-market quality, including CAPA and complaint handling.
• Support the full regulatory arc, from near-term 510(k) through a longer-term Class III PMA and combination-product pathway, and prepare the organization for the compliance requirements each stage brings.
• Lead supplier quality, including qualification, monitoring, and ongoing management.
• Partner closely with R&D, engineering, operations, and leadership so quality is a built-in part of how the company works rather than a downstream checkpoint.

Qualifications

• Significant medical device quality experience (required). Candidates without a medical device background will not be a fit for this role.
• Deep working knowledge of ISO 13485, 21 CFR 820 / QMSR, and ISO 14971.
• Proven ownership of a Quality Management System, ideally including building or substantially standing one up rather than only maintaining an established system.
• Experience leading internal, external, and supplier audits, and hosting regulatory or notified body audits.
• A track record authoring SOPs and driving real adherence across an organization.
• Post‑market quality experience, including CAPA and complaint handling.
• Experience supporting regulatory submissions. Near‑term that means 510(k); candidates who can also scale with us toward a Class III PMA and combination‑product submissions will stand out.
• Experience building and leading a quality team.
• A genuine partner mindset: the credibility to set standards and the collaborative instinct to make them stick without becoming a bottleneck.
• Comfort operating with autonomy and a build‑it‑yourself mandate in an early‑stage environment.

Preferred

• Combination device and / or complex Class III electromechanical device experience.
• Experience taking products through 510(k) and PMA pathways.
• Experience taking a novel or first‑of‑its‑kind device from development toward manufacturing and submission.
• Exposure to biologics‑adjacent or biological handling contexts.