Sr. Manager, Quality Design Assurance

About the Job:

The Sr Mgr, Quality Design Assurance owns end‑to‑end quality for FMI’s regulated medical devices and IVD development processes. Partnering closely with Product Development, Regulatory Affairs, Quality Systems, Complaints, Risk Management, R&D, and Global Lab Operations, this role provides strategic leadership, governance, and operational oversight to ensure products are designed and developed with patients and users at the center, safe, high quality, and inspection ready. 

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

The Senior Manager leads and develops a high performing 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 Design Assurance lead for Product Development of Medical Devices and IVDs Program Leadership 
  • Lead the global Medical Device and IVD Design Assurance program strategy and execution across FMI, ensuring a risk-based, effective, and inspection-ready approach to product development. 
  • Establish clear expectations for design 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, 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 product development Medical Device Product and IVD 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 Product Development related KPIs, trends, and systemic risks to Quality leadership and senior governance forums. 
  • Working with Product and Research and Development lead enhancements to Product Development process in the area of Design Assurance and Risk Management, workflows, data integrity, reporting, and system performance. 
  • Act as the Design Assurance 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 Design Assurance 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 Design Assurance 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 
• 6+ years of experience in quality, IVDR, medical device, or other regulated biotechnology environments 
• 2+ years of management experience  

Preferred Qualifications:

• Demonstrated experience harmonizing Medical Device Product Development practices across multiple sites or regions.    
• Experience supporting or leading eQMS implementation or optimization, including collaboration with IT and business stakeholders.    
• Experience serving as a Design Assurnace or QMS subject matter expert during regulatory inspections (e.g., FDA, ISO, MDSAP).   
• Familiarity with clinical laboratory quality systems (CLIA) and interfaces between laboratory, device, and clinical trial quality.    
• Experience applying lean principles or continuous improvement methodologies within quality systems.    
• Knowledge of or experience with next-generation sequencing (NGS), molecular diagnostics, or complex laboratory technologies.   
• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving.   
• Strong conceptual, analytical, and problem-solving abilities.  
• Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects, and meet deadlines  
• Ability to travel based on business needs, typically 10-20%, but flexing higher when needed.   
• Understanding of HIPPA and importance of patient data privacy   
• Commitment to reflect FMI’s values: Integrity, Courage, and Passion 

The expected salary range for this position based on the primary location of Boston, MA is $153,200 – $191,500  per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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