Director, Supplier Quality Engineering

TL;DR

Director, Supplier Quality Engineering (Medical Devices): Provide strategic and operational leadership for supplier quality engineering supporting manufacturing operations in the United States and China, with an accent on supplier quality systems, regulatory compliance, and multi-tier supply chain performance. Focus on building organizational capabilities, resolving supplier nonconformances via SCAR and root cause investigations, and ensuring compliance with FDA QSR, ISO 13485, MDR, and MDSAP while reducing COPQ and production disruptions.

Location: Chelmsford, MA (on-site; applicants must reside within a reasonable commuting distance)

Salary: $190,000.00 to $210,000.00 annually

Company

hirify.global develops and delivers lifesaving medical devices and related software and services for acute care and emergency response customers worldwide.

What you will do

• Lead and develop the global Supplier Quality organization supporting manufacturing sites in the U.S. and China, including vision, strategy, roadmap, and succession planning.
• Drive day-to-day supplier quality execution: resolve incoming inspection issues, manage supplier nonconformances, lead SCARs and root cause investigations, and escalate production-impacting supplier issues.
• Oversee supplier documentation, qualification, validations, and supplier change requests to ensure consistent quality and compliance.
• Improve supplier performance through scorecards, business reviews, supplier development initiatives, and processes to reduce supplier-related COPQ.
• Support New Product Introductions and regulatory compliance by partnering on supplier selection/qualification for NPIs, audits, and inspections, ensuring alignment with FDA QSR, ISO 13485, MDR, and MDSAP.

Requirements

• 10+ years in Supplier Quality/Quality Engineering in regulated manufacturing.
• 5+ years leading Supplier Quality organizations.
• Bachelor’s degree in Engineering, Quality, Supply Chain, or related field (Master’s preferred).
• Experience supporting complex electromechanical products, global suppliers, and medical devices (preferred).
• On-site requirement: must reside within a reasonable commuting distance of Chelmsford, MA.
• No immigration-related sponsorship: do not apply if you will need ZOLL immigration sponsorship now or in the future.

Culture & Benefits

• Annual bonus eligibility under the company bonus plan.
• Comprehensive benefits plans available (details provided by the employer).
• Fast-growing organization with a mission focused on improving patient outcomes.
• Culture emphasizes innovation, self-motivation, and an entrepreneurial spirit.
• Applications reviewed on an ongoing basis until the position is filled.