Job Title

Job Description

The Site Leader (Director), Operations Quality Assurance is responsible for leading the Quality function across the Best 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 Best 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.

You're the Right Fit If you have:

• You have minimum 15+ years experience in FDA-regulated (ISO 13485) medical device manufacturing environments, with a focus on site leadership, quality Operations, audit/audit readiness, process validation/improvement, CAPA, non-conformance and Change/Risk Management (ISO 14971).
• You have minimum 5+ years’ experience proven leadership managing teams in one or more of these areas: Quality Systems, Manufacturing Quality, Supplier Quality, CAPA, Nonconformance Management, Validation, Product Release, and Continuous Improvement.
• You possess deep knowledge of FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and global medical device quality requirements.
• You have experience of serving as a Quality Management Representative and leading organizations through regulatory inspections and external audits.
• You have successfully led quality transformation, remediation, compliance improvement, or operational excellence initiatives.
• You have strong experience using quality metrics and business performance indicators to drive risk based decision-making and continuous improvement.
• You are an effective strategic and operational leader with strong influencing, collaboration, communication, and change management skills.
• You demonstrate executive presence and are comfortable engaging with senior leadership, auditors, regulators, and external stakeholders.
• You have a Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field. An advanced degree is preferred.

Compensation & benefits
Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is EUR 93,049.00 - EUR 155,081.00 gross per year. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations. 

This role is eligible for 6% short term incentive with your rewards linked to both individual performance and company results. We’ll share the full approach with you during the interview process, so you can make a clear, informed decision. Benefits include paid time-off, health and wellbeing benefits, learning and development opportunities.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an onsite role.
About Philips
Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care.

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