Director, Supplier Quality Engineering

ZOLL Medical Corporation•Chelmsford, MA

2d•$190,000 - $210,000•Onsite

About The Position

The Director of Supplier Quality Engineering reports to the Vice President of Procurement and provides strategic and operational leadership for the Supplier Quality Engineering organization supporting manufacturing operations in the United States and China. This role is responsible for ensuring supplier quality, supplier parts validations, regulatory compliance, and supplier performance across a global, multi-tier supply chain supporting complex electromechanical medical devices. The Director partners closely with Sourcing, R&D, Quality Assurance, Regulatory Affairs, Operations, and Manufacturing Engineering to ensure suppliers consistently meet quality, delivery, and compliance requirements. The position oversees both day-to-day supplier quality activities and the development of long-term supplier quality strategies, processes, and organizational capabilities that improve supplier performance, reduce risk, and lower the Cost of Poor Quality (COPQ) at suppliers.

Requirements

Bachelor's degree in Engineering, Quality, Supply Chain, or related field; Master's preferred.
10+ years in Supplier Quality/Quality Engineering in regulated manufacturing.
5+ years leading Supplier Quality organizations.
Experience with complex electromechanical products, global suppliers, and medical devices preferred.
Strategic leadership
Coaching and Mentoring
Supplier quality systems
Cross-functional collaboration
Continuous improvement
Supplier development
Regulatory expertise

Responsibilities

Lead and develop the global Supplier Quality organization supporting manufacturing sites in the U.S. and China.
Establish the vision, strategy, and roadmap for Supplier Quality Management.
Build organizational capabilities, develop talent, and create succession plans.
Define and report performance metrics and drive continuous improvement.
Resolve incoming inspection issues and supplier nonconformances.
Lead SCARs and root cause investigations.
Oversee supplier documentation, qualification, validations, and supplier change requests.
Escalate and resolve supplier issues affecting production.
Develop supplier scorecards and business reviews.
Drive supplier development initiatives.
Establish processes to reduce supplier-related COPQ.
Partner with Procurement to improve supplier performance and mitigate risk.
Support supplier selection and qualification for NPIs.
Partner with R&D and Engineering on product launches and engineering changes.
Ensure compliance with FDA QSR, ISO 13485, MDR, and MDSAP.
Support supplier audits and regulatory inspections.