Quality Systems Lead

Lumicity; San Francisco (CA); Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

QMS leadership

Regulatory compliance

Design controls

Cross-functional leadership

Documentation control

CAPA

Internal audits

Ausbildung

Bachelor's degree in Engineering or Life Sciences

Tools

Audit management software

CAPA software

eQMS platforms

Jobbeschreibung

We are seeking a Quality Systems Lead to build and scale the quality infrastructure for an early-stage medical device company. This is a hands-on role for an experienced quality professional who has successfully implemented and operationalized Quality Management Systems (QMS) and design controls in a medical device environment.

The ideal candidate has experience working in a startup or other fast-paced environment where they have had to build practical, compliant processes from the ground up rather than simply maintain an established QMS. Experience supporting FDA 510(k) submissions is highly desirable.

You will work cross-functionally with Engineering, Product Development, Regulatory, Clinical, Operations, and Leadership to establish quality systems that enable rapid product development while maintaining compliance with applicable medical device regulations and standards.

Key Responsibilities

QMS Implementation & Management

• Lead the design, implementation, and continuous improvement of the company's Quality Management System.
• Establish scalable quality processes, procedures, work instructions, and quality records appropriate for an early-stage medical device organization.
• Develop and implement processes covering areas such as document control, training, CAPA, nonconformance, complaint handling, supplier quality, change control, internal audits, and management review.
• Ensure the QMS supports applicable FDA requirements, including 21 CFR Part 820, as well as relevant international standards such as ISO 13485.
• Establish quality metrics and monitoring processes to assess QMS effectiveness.
• Prepare the organization for regulatory inspections and third-party audits.

Design Controls & Product Development

• Lead implementation and execution of medical device design control processes throughout the product development lifecycle.
• Establish and maintain design inputs, outputs, design reviews, verification, validation, design changes, and design history documentation.
• Partner closely with Engineering and Product Development to integrate quality requirements into the development process without unnecessarily slowing innovation.
• Provide guidance on risk management, including integration of ISO 14971 principles into product development.
• Ensure design and development documentation is complete, traceable, and inspection-ready.

Regulatory & 510(k) Support

• Support Regulatory Affairs and product development teams in preparation of FDA 510(k) submissions and associated technical documentation.
• Provide quality systems and design control expertise for regulatory submissions.
• Support development of submission-ready design history and verification/validation documentation.
• Participate in interactions with FDA and other regulatory bodies as needed.

Quality & Compliance

• Establish processes for identifying, investigating, and addressing quality issues, including CAPAs and nonconformances.
• Support supplier qualification and ongoing supplier quality management.
• Establish internal audit programs and coordinate external audits.
• Identify compliance gaps and lead remediation activities.
• Promote a culture of quality, accountability, and continuous improvement across the organization.

Cross-Functional Leadership

• Serve as the quality subject matter expert across the company.
• Train and mentor employees on QMS requirements and quality processes.
• Work collaboratively with Engineering, Regulatory, Operations, Clinical, and Executive Leadership.
• Balance regulatory requirements with the practical needs of a growing startup.
• Help establish a quality culture that scales with the company and its products.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical field.
• 5+ years of experience in medical device quality, with increasing responsibility in Quality Systems and/or Product Development Quality.
• Demonstrated hands-on experience implementing or significantly building a medical device QMS.
• Demonstrated experience implementing and executing design controls for medical device development.
• Strong knowledge of FDA medical device quality requirements and 21 CFR Part 820.
• Working knowledge of ISO 13485 and ISO 14971.
• Experience with document control, CAPA, nonconformance, change control, training, supplier quality, and internal audits.
• Experience working cross-functionally with Engineering and Product Development teams.
• Strong understanding of design history files and design verification/validation.

Preferred Qualifications

• Experience supporting one or more FDA 510(k) submissions.
• Experience in a medical device startup or other early-stage company.
• Experience establishing a QMS from the ground up.
• Experience with FDA inspections or ISO 13485 certification audits.
• Experience with electronic QMS (eQMS) implementation.
• Familiarity with software-enabled or combination medical devices, depending on product portfolio.
• ASQ certification such as CQE, CQA, or CQM is a plus.