Director, Quality Programs-Integrated Supply Chain; ISC)

Director, Quality Programs-Integrated Supply Chain (ISC)

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, 21
  
  CFR (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…