Senior Quality Manager – Advanced Imaging

About the role

The Senior Quality Manager‑Advanced Imaging provides leadership for the Quality Management System (QMS) and Design Assurance functions, ensuring safe, effective, and compliant Image Guided Therapy products throughout the product lifecycle.

Key responsibilities

• Lead the Quality Management System (QMS) and ensure compliance with global regulations such as FDA QMSR, ISO 13485, and EU MDR.
• Serve as the primary quality representative for regulatory inspections, external audits and interactions with notified bodies.
• Establish, maintain and continuously improve quality processes, design assurance activities and risk‑management practices across the product lifecycle.
• Drive data‑based decision making by monitoring quality metrics, CAPA, non‑conformance and root‑cause analyses.
• Partner with R&D, Operations, Regulatory Affairs and other functions to resolve quality issues and support business objectives.
• Lead a high‑performing quality organization through talent acquisition, performance management and employee development.

Required profile

• Minimum 8 + years of experience in FDA‑regulated medical device environments with responsibility for QMS compliance and design assurance.
• Proven experience managing quality teams, budgeting, workforce planning and succession planning.
• Strong knowledge of medical device regulations and standards including ISO 13485, ISO 14971, 21 CFR 820, EU MDR, GMP and GDP.
• Bachelor’s degree in Quality, Engineering or a related discipline.

Required skills

• FDA QMSR and 21 CFR (803, 806, 820) compliance
• ISO 13485 quality management
• ISO 14971 risk management, DFMEA/PFMEA
• European Medical Device Regulation (MDR)
• Lean and Six Sigma methodologies
• Quality KPI analysis and data‑driven improvement

What we offer

• Salary range $134,000 – $213,000 per year, plus potential annual incentive bonus.
• Comprehensive total‑rewards package including generous PTO, 401(k) match up to 7 %, HSA contributions, stock purchase plan and education reimbursement.