Senior Quality Operations Manager – Advanced Imaging

About the role

The Senior Quality Operations Manager – Advanced Imaging leads strategic quality initiatives for Philips’ advanced imaging products. You will oversee process validation, drive continuous improvement, manage CAPA and non‑conformance activities, and ensure compliance with FDA and ISO standards.

Key responsibilities

• Lead and develop the Quality team, handling talent acquisition, performance management, compensation, and career development.
• Own the CAPA process, investigating non‑conformances, performing root‑cause analysis, implementing corrective actions, and monitoring effectiveness.
• Plan and assess Process Failure Mode and Effects Analysis (PFMEA) and support manufacturing process development and design transfer.
• Oversee product transfer validations, report on new product introduction status, and ensure validation activities meet quality norms.
• Drive supplier quality improvement initiatives in collaboration with R&D, manufacturing, and regulatory affairs.

Required profile

• 10+ years of experience in FDA‑regulated (ISO 13485) medical device quality operations, including audit support, process validation, and risk management (ISO 14971).
• 3+ years of proven experience managing quality teams, budgeting, workforce planning, and employee development.
• Extensive experience managing CAPA, non‑conformance, PFMEA, and change/risk management processes.
• Strong ability to use quality, reliability and post‑market surveillance data analytics to drive continuous improvement.

Required skills

• FDA regulations and ISO 13485 compliance
• ISO 14971 risk management
• CAPA management
• PFMEA analysis
• Process validation and transfer
• Sterilization validation and environmental control programs
• Quality data analytics

What we offer

• Base salary range $134,000 – $213,000 per year.
• Comprehensive benefits including generous PTO, 401(k) match up to 7%, HSA contributions, stock purchase plan, and education reimbursement.