Director, Operations Quality Assurance – Ultrasound

About the role

The Director, Operations Quality Assurance – Ultrasound leads the quality function across Philips’ Reedsville and Bothell ultrasound manufacturing sites. The role provides strategic and operational leadership to ensure compliance with regulatory requirements, Philips standards, and business objectives while safeguarding product quality and patient safety.

Key responsibilities

• Lead all Operations Quality Assurance activities, develop and execute the quality strategy, and drive a culture of quality and compliance.
• Represent the organization as Quality Management Representative during FDA inspections, Notified Body audits, and customer audits, maintaining continuous inspection readiness.
• Drive timely resolution of audit findings, non‑conformances, and CAPA activities through root‑cause analysis and sustainable corrective actions.
• Establish and monitor quality metrics, management review processes, and risk‑based decision making to improve performance.
• Partner with Operations, R&D, Regulatory Affairs, Supply Chain and Business Leadership to mitigate quality risks and support product realization.

Required profile

• 10+ years of progressive leadership experience in FDA‑regulated medical device manufacturing.
• Proven experience as a Quality Management Representative leading organizations through regulatory inspections and external audits.
• Deep knowledge of FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR and other global medical device quality requirements.
• Demonstrated ability to lead quality transformation, remediation, and continuous‑improvement initiatives.

Required skills

• FDA regulations
• ISO 13485
• ISO 14971
• MDSAP
• EU MDR
• CAPA
• Nonconformance Management
• Validation

What we offer

• Salary range $162,000 – $258,000 per year.
• Annual incentive bonus and long‑term incentive opportunities.
• Comprehensive total‑rewards benefits including generous PTO, 401(k) match up to 7%, HSA contributions, stock purchase plan and education reimbursement.