Job Title

Job Description

The Director, Quality Programs-Integrated Supply Chain (ISC) provides strategic leadership for enterprise and site-level quality programs within FDA regulated medical-device manufacturing environments. This role will lead large scale, global, cross-functional programs that strengthen the quality management system, improve compliance, reduce risk, and advance operational excellence.

Your role:

Leadership and Team Management:

• Lead, mentor, and manage a team of Program Managers and data analyst responsible for quality programs.
• Foster a collaborative and high-performance culture within the team.
• Provide guidance, support, and development opportunities to ensure team effectiveness and professional growth.

Strategic Planning and Execution:

• Develop and implement strategic plans for quality programs, including Artificial Intelligence (AI), that align with organizational goals and regulatory requirements.
• Oversee the planning, execution, and completion of quality compliance projects to ensure they lead them in accordance with timelines, budgets, and objectives.
• Identify and address potential risks and issues that could impact project success.

Product Quality, Quality Management System, Compliance and Standards:

• Ensure adherence to industry standards, regulatory requirements, and internal quality policies.
• Monitor and evaluate the effectiveness of quality programs, making adjustments as needed to maintain compliance and improve outcomes.
• Stay informed about industry trends and best practices to continuously enhance quality programs.
• Lead improvements in data and analytics by improvement current tools and practices

Cross-Functional Collaboration:

• Collaborate with other departments, including Operations Quality, Operations, Engineering, Business , and Supply Chain, on programs and outcomes.
• Serve as the primary point of contact for quality-related inquiries and concerns from internal stakeholders.

Reporting and Documentation:

• Prepare and present reports on project status, performance metrics, and compliance to senior management.
• Ensure accurate and timely documentation of quality program activities, including project plans, reports, and compliance records.

Continuous Improvement:

• Drive a culture of continuous improvement by implementing best practices and innovative solutions to enhance quality and efficiency.
• Lead initiatives to identify opportunities for process improvements and implement corrective actions as needed

You're the right fit if:

• You have a minimum of 10+ years’ experience in FDA regulated medical device manufacturing/supply chain environments, providing strategic leadership for large scale, global, cross-functional quality programs/projects.
• You have a proven track record of successful program/project management, transformation, change management, continuous improvement and team leadership in a matrix environment
• You have proven experience in functional management of PMO/Quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
• You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
• You have proven expertise utilizing/improving data analytics- Quality KPI’s/Data Analysis to assess program/quality/team performance and identify process and continuous improvement opportunities.
• You’re able to effectively communicate, influence and build relationships with cross-functional team members at ALL levels.
• You have a minimum of a Bachelor’s degree in Quality, Engineering or a related Scientific discipline (required). Advanced degree or relevant certifications (e.g., Six Sigma, PMP) preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. 

How we work together:

We believe that we are better together than a part. 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 Office role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Additional Information:

• Company relocation benefits will not be provided for this position.  For this position, you must reside in or within commuting distance to Alajuela, Costa Rica (Coyol Free Zone).
• This role may require travel up to 25%.