The Position:

We are looking for an energetic and self-motivated Quality professional who will be excited to build an IVD QA team and lead the implementation of a new IVDR-compliant Quality Management System.

In this role, the Senior IVD QA Manager will be responsible for building an IVD Quality team and managing this team in the development and implementation of a Quality Management System that includes quality processes and procedures, automated systems, and ensuring compliance with all applicable internal, domestic, and international quality regulations, including ISO 13485, IVDR, and others global regulations and standards. This is a hybrid role (in office at least 3 days a week) and is based out of our headquarters in South San Francisco (SSF), California, United States.

• Develop, implement, and maintain a Quality Management System (QMS) in accordance with ISO 13485 and applicable standards and regulations for in vitro diagnostic (IVD) products.

• Develop and monitor QMS metrics and quality records to ensure timely review, closure, and continuous improvement of system effectiveness.

• Drive continuous improvement across the quality system to support scalability, compliance, and operational efficiency.

• Oversee implementation and administration of an electronic QMS (eQMS), including system configuration, user training, and ongoing maintenance.

• Manage core quality system processes, including document control, training, change control, nonconformance handling, CAPA, and internal audits.

• Plan, conduct, and document internal audits; track audit findings and ensure effective implementation of corrective and preventive actions.

• Support supplier qualification and oversight, including supplier audits, performance monitoring, quality issue resolution, and Quality Agreement management.

• Collaborate with external partners such as contract manufacturers and laboratories to ensure quality expectations and regulatory requirements are met.

• Lead Management Review meetings.

• Lead and deliver quality training to staff to ensure competency and adherence to QMS procedures.

• Maintain a proactive state of audit/inspection readiness and lead external audits by regulatory bodies, partners, or customers.

Who You Are:

• BS/BA degree in a science-related or technical field or equivalent combination of work experience.
• Minimum 10 years progressively responsible work experience in medical device or regulated industries.
• Minimum 6 years of direct supervisory experience.
• Working knowledge of IVD-specific quality system requirements, including application of ISO 13485 in the design & development and validation of IVD products; knowledge of FDA Quality System Regulations a nice to have.
• Provide direction and leadership for product quality and compliance.
• Ability to collaborate across functions and technical teams, including IVD development and contract manufacturers, is a must.
• Experience implementing and/or managing Document Control using an electronic Quality Management System (eQMS).
• In depth knowledge of core quality system processes including CAPA, nonconformance management, audits, training, document control, and change control.
• Experience conducting internal audits and leading external ISO audits or third-party assessments.
• Strong organizational skills to manage multiple simultaneous projects in a fast-paced environment.
• Attention to detail in understanding and documenting complex quality issues.
• Strong writing skills to summarize complex issues clearly and accurately.
• Strong communication, problem-solving, and motivational skills.
• Highly organized, self-motivated, and comfortable working in a fast-paced IVD environment.
• Familiarity with CLIA requirements and operational considerations for laboratory-developed tests (LDTs) is a nice to have.
• Expected domestic travel up to 20%.

#LI-Hybrid