Site Leader (Director), Operations Quality Assurance-Ultrasound

Philips•Reedsville, PA

20d•Onsite

About The Position

The Site Leader (Director), Operations Quality Assurance is responsible for leading the Quality function across the Reedsville and Bothell Ultrasound manufacturing sites. This role provides strategic and operational leadership to ensure all medical devices, manufacturing processes, and quality system activities comply with applicable regulatory requirements, Philips standards, and business objectives. Your Role: Lead all Operations Quality Assurance activities across the Reedsville and Bothell manufacturing sites, ensuring compliance, product quality, patient safety, and operations quality performance. Accountable for developing and executing the Operations Quality Strategy, translating enterprise quality objectives into measurable site-level priorities/results, driving a culture of quality and compliance, ensuring inspection readiness, and continuously improving quality performance across the sites. As the senior Quality leader and designated Quality Management Representative, the Director represents the organization during regulatory inspections/external audits, ensures the effectiveness and compliance of the Quality Management System and partners closely with Operations, R&D, Regulatory Affairs, Supply Chain, and Business Leadership to ensure product quality, patient safety, and business continuity. Ensure all products, manufacturing processes, and quality system activities comply with FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and other applicable global requirements. Lead and represent the sites during FDA inspections, Notified Body audits, customer audits, and regulatory authority interactions, maintaining a continuous state of inspection readiness. Drive timely resolution of audit findings, compliance gaps, nonconformances, and CAPA activities through robust root cause analysis and sustainable corrective actions. Provide leadership for Manufacturing Quality, Quality Systems, CAPA, Nonconformance Management, Validation Quality Oversight. Establish and monitor quality metrics and management review processes to identify risks, improve performance, and ensure quality system effectiveness. Drive a strong culture of quality, compliance, accountability, continuous improvement, and operational excellence throughout the organization. Partner with Operations and cross-functional leadership to proactively identify and mitigate quality risks while supporting business growth and product realization. Lead quality transformation, remediation, and continuous improvement initiatives to strengthen compliance, process capability, and customer satisfaction. Build and develop a high-performing Quality organization through talent management, succession planning, coaching, and organizational development.

Requirements

10+ years of progressive leadership experience in FDA-regulated medical device manufacturing environments.
Demonstrated leadership across Quality Systems, Manufacturing Quality, Supplier Quality, CAPA, Nonconformance Management, Validation, Product Release, and Continuous Improvement.
Deep knowledge of FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and global medical device quality requirements.
Experience serving as a Quality Management Representative and leading organizations through regulatory inspections and external audits.
Successfully led quality transformation, remediation, compliance improvement, or operational excellence initiatives.
Strong experience using quality metrics and business performance indicators to drive risk-based decision-making and continuous improvement.
Effective strategic and operational leader with strong influencing, collaboration, communication, and change management skills.
Executive presence and comfortable engaging with senior leadership, auditors, regulators, and external stakeholders.
Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Nice To Haves

An advanced degree is preferred.

Responsibilities

Lead all Operations Quality Assurance activities across the Reedsville and Bothell manufacturing sites, ensuring compliance, product quality, patient safety, and operations quality performance.
Develop and execute the Operations Quality Strategy, translating enterprise quality objectives into measurable site-level priorities/results.
Drive a culture of quality and compliance, ensuring inspection readiness, and continuously improving quality performance across the sites.
Represent the organization during regulatory inspections/external audits as the senior Quality leader and designated Quality Management Representative.
Ensure the effectiveness and compliance of the Quality Management System.
Partner closely with Operations, R&D, Regulatory Affairs, Supply Chain, and Business Leadership to ensure product quality, patient safety, and business continuity.
Ensure all products, manufacturing processes, and quality system activities comply with FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and other applicable global requirements.
Lead and represent the sites during FDA inspections, Notified Body audits, customer audits, and regulatory authority interactions, maintaining a continuous state of inspection readiness.
Drive timely resolution of audit findings, compliance gaps, nonconformances, and CAPA activities through robust root cause analysis and sustainable corrective actions.
Provide leadership for Manufacturing Quality, Quality Systems, CAPA, Nonconformance Management, Validation Quality Oversight.
Establish and monitor quality metrics and management review processes to identify risks, improve performance, and ensure quality system effectiveness.
Drive a strong culture of quality, compliance, accountability, continuous improvement, and operational excellence throughout the organization.
Partner with Operations and cross-functional leadership to proactively identify and mitigate quality risks while supporting business growth and product realization.
Lead quality transformation, remediation, and continuous improvement initiatives to strengthen compliance, process capability, and customer satisfaction.
Build and develop a high-performing Quality organization through talent management, succession planning, coaching, and organizational development.