Manager, CDx Quality Assurance

About the Job:

The Manager, Companion Diagnostic (CDx) Quality Assurance owns end‑to‑end quality for FMI's CDx development programs for regulated medical devices and IVDs. Partnering closely with Regulatory Affairs, Quality Systems, Complaints, Risk Management, Diagnostic Development and Validation, Clinical Operations, R&D, and Global Lab Operations, this role provides leadership, governance, and operational oversight to ensure CDx programs are executed with patients and users at the forefront, safety, and high quality as the north star.

This role is critical to advancing organizational learning, continuous improvement, and sustained patient safety through a mature, scalable CDx product development framework.

The Manager leads and develops a team of quality professionals while strengthening investigation rigor and decision‑making across the organization, applying sound judgment in complex, highly regulated environments.

Key Responsibilities:

* Global CDx Quality Assurance lead for Medical Devices and IVDs

* Lead the global CDx Quality Assurance Medical Device and IVD Development program strategy and execution across FMI, ensuring a risk-based, effective, and inspection-ready approach to CDx product development.

* Establish clear expectations for CDx Quality Assurance within the product development process throughout the total product lifecycle.

* Partner with senior Quality leadership to align Medical Device and IVD Product Development governance with broader FMI organization responsible for Product Development, including but not limited to Regulatory Affairs, Clinical Operations, Product, Research and Development, Operations. .

* Cross Functional Partnership & Risk Management

* Partner with cross functional stakeholders (Quality, Regulatory Affairs, Diagnostic Development and Validation, Clinical Operations Product, Research and Development, Operations, Laboratory, IT, and Clinical/Lab interfaces) to ensure Medical Device Products and IVD are developed with patient safety first and right the first time mentality.

* Serve as a subject matter expert on CDx product development leadership teams across IVDs and clinical trial interfaces.

* Ensure CAPA outputs appropriately inform Complaints, Risk Management, Issue Impact Assessments, and Management Review.

* Data, Metrics & Technology Enablement

* Develop, monitor, and communicate CDx Product Development related KPIs, trends, and systemic risks to Quality leadership and senior governance forums.

* Working with Product, Diagnostic Development and Validation, Clinical Operations and Research and Development collaborate on enhancements to CDx Product Development process in the area of Design Assurance, Clinical Trials and Risk Management, workflows, data integrity, reporting, and system performance.

* Act as the CDx Product Development Process quality business owner and quality representative for technology initiatives, ensuring solutions are compliant, scalable, and fit for purpose.

* Inspection Readiness & Regulatory Support

* Serve as a CDx Product Development subject matter expert during regulatory inspections, audits, and internal governance reviews.

* Ensure inspection ready documentation, clear investigation narratives, and defensible corrective action strategies.

* People Leadership & Capability Building

* Lead, coach, and develop a team of quality professionals, strengthening investigation rigor, critical thinking, and quality judgment.

* Partner with Quality and functional leaders to project CDx Quality Assurance Product Development demand and resource needs to maintain program sustainability.

* Drive continuous improvement through trend analysis, effectiveness reviews, and lessons learned to reduce patient and business risk.

Qualifications:

Basic Qualifications:

* Bachelor's degree in science, engineering or related field

* 5+ years of experience in quality, IVDR, medical device, or other regulated biotechnology environments

* 1+ years of management experience

Preferred Qualifications:

* Demonstrated experience harmonizing Medical Device Product Development, including Clinical Trials practices across multiple sites or regions.

* Experience supporting or…