Sr. IVD QA Manager

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.
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.

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.

Familiarity with CLIA requirements and operational considerations for laboratory-developed tests (LDTs) is a nice to have.