Senior Quality Operations Manager – Ultrasound

About the role

The Senior Quality Operations Manager will lead the quality team at Philips' Reedsville Ultrasound Transducer manufacturing site, overseeing quality operations, continuous improvement initiatives and site compliance.

Key responsibilities

• Manage the Corrective and Preventive Actions (CAPA) process, investigate non‑conformances, determine root causes and monitor effectiveness.
• Plan and assess impact to Process Failure Mode and Effects Analysis (PFMEA) for design changes and support manufacturing process development.
• Oversee testing robustness of product transfer validations, report project status for new products and ensure validation activities meet quality norms.
• Drive strategic initiatives to raise supplier quality standards in collaboration with R&D, manufacturing and regulatory affairs.
• Lead resolution of quality non‑conformities with internal suppliers and act as local QMS process owner for process validation.
• Manage talent across the team, including hiring, performance management, compensation and career development.

Required profile

• Minimum 7+ years’ experience in FDA‑regulated medical device manufacturing, focusing on operations/process quality, CAPA, audits and process validation.
• Proven functional management experience of quality teams, including budgeting, workforce planning and employee engagement.
• Strong knowledge of medical device regulations and standards such as ISO 13485, ISO 14971, 21CFR, MDD/EU MDR, GMP and GDP.
• Experience using quality KPIs and data analysis to drive continuous improvement.
• Excellent communication and influencing skills to work with cross‑functional teams, suppliers and regulatory agencies.

Required skills

• CAPA management
• PFMEA
• IQ/OQ/PQ
• ISO 13485
• ISO 14971
• 21CFR compliance
• MDD/EU MDR knowledge
• GMP and GDP
• Quality KPI/Data analysis

What we offer

• Salary range $120,000 – $190,000 per year.
• Comprehensive benefits including generous PTO, 401(k) match up to 7%, HSA contributions, stock purchase plan and education reimbursement.