Director, Quality Programs-Integrated Supply Chain (ISC)

Philips•Plymouth, MN

10d•Hybrid

About The Position

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.

Requirements

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.
Proven track record of successful program/project management, transformation, change management, continuous improvement and team leadership in a matrix environment
Proven experience in functional management of PMO/Quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
Strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
Proven expertise utilizing/improving data analytics- Quality KPI’s/Data Analysis to assess program/quality/team performance and identify process and continuous improvement opportunities.
Able to effectively communicate, influence and build relationships with cross-functional team members at ALL levels.
Minimum of a Bachelor’s degree in Quality, Engineering or a related Scientific discipline (required).
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Nice To Haves

Advanced degree or relevant certifications (e.g., Six Sigma, PMP) preferred.

Responsibilities

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.
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.
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
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.
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.
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