Director, Quality & AI Programs - Integrated Supply Chain

Regulatory Jobs; Plymouth, Cambridge (MN, MA); On-site; USD 170,000 - 270,000; Full time

Benefits offered by this job

PTO

401k with match

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips in Plymouth, MN seeks a Director of Quality Programs-Integrated Supply Chain (ISC) to lead enterprise and site-level quality programs in FDA-regulated medical-device manufacturing. You will guide large-scale, global programs, manage a PMO/quality team, and ensure compliance with ISO 13485/14971 and 21 CFR standards.

You will oversee strategic planning, execution, and continuous improvement, leveraging data analytics to improve outcomes, reduce risk, and drive operational excellence; this

Qualifications

• Minimum 10+ years in FDA-regulated medical device manufacturing/supply chain with strategic leadership for global quality programs/projects.
• Proven program/project management experience in a matrix environment (PMO/Quality teams).
• Budgeting, workforce planning, performance management, employee engagement/retention, succession planning, coaching, training.
• Strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21 CFR 803, 806, 820, MDD/EU MDR, GMP, GDP.
• Proven expertise using/analyzing data analytics to assess program performance and drive improvements.
• Bachelor’s degree required; advanced degree or certifications preferred.

Responsibilities

• Lead, mentor, and manage a team of Program Managers and data analysts focused on quality programs.
• Foster a collaborative, high-performing culture across cross‑functional teams.
• Develop and execute strategic plans for quality programs, including AI initiatives, aligned with regulatory requirements.
• Oversee quality compliance projects within timelines and budgets; identify risks and mitigations.
• Ensure adherence to regulatory requirements and internal quality policies; monitor program effectiveness.
• Drive continuous improvement through data-driven initiatives and best practices.

Skills

Leadership

Team management

Cross-functional collaboration

Data analytics

Regulatory knowledge

Communication

Strategic thinking

Education

Bachelor’s degree in Quality, Engineering or related Scientific discipline

Advanced degree or certifications (Six Sigma, PMP) preferred

Job description

Philips in Plymouth, MN seeks a Director of Quality Programs-Integrated Supply Chain (ISC) to lead enterprise and site-level quality programs in FDA-regulated medical-device manufacturing. You will guide large-scale, global programs, manage a PMO/quality team, and ensure compliance with ISO 13485/14971 and 21 CFR standards.

You will oversee strategic planning, execution, and continuous improvement, leveraging data analytics to improve outcomes, reduce risk, and drive operational excellence; this