GSQ QMS Leader; Global

GSQ QMS Leader (Global)

Global Supplier Quality (GSQ) QMS Leader (Global)

We are seeking an experienced leader to define and drive strategic transformation initiatives across Quality and Supplier ecosystems within a regulated medical device environment. This role will lead cross‑functional programs focused on AI enablement, digital solutions, and process optimization, while also governing and advancing the globally shared Quality Management System (QMS) for Supplier Quality (Shared Services). The role operates at the intersection of quality, technology, and operations, ensuring scalable, compliant, and future‑ready solutions that enhance performance and patient safety.

• Define and execute a portfolio of strategic Supplier Quality initiatives aligned to business priorities, supported by multi‑year transformation roadmaps with clear KPIs and value outcomes. Establish governance, prioritization frameworks, and executive‑level reporting to ensure disciplined execution and visibility.
• Own and continuously optimize the global Supplier Quality QMS, including standardized procedures, workflows, and governance frameworks across all business units. Ensure consistent adoption, regulatory compliance, and sustained audit readiness through robust performance metrics and monitoring.
• Lead the strategy and deployment of digital and AI‑enabled solutions to enhance Quality processes, ensuring scalability, system integration, and data‑driven decision‑making. Partner cross‑functionally to ensure all solutions meet regulatory expectations for validation, lifecycle management, and risk control.
• Drive global harmonization and simplification of Supplier Quality processes by embedding best practices and sustainable governance models across regions. Enable continuous improvement through digitization, streamlined workflows, and integrated systems.
• Influence senior stakeholders across Quality, Engineering, Procurement, Regulatory, and IT to align priorities and deliver transformation ed risk‑based thinking and quality‑by‑design principles while ensuring full compliance with global regulatory requirements and maintaining continuous audit readiness.

• You’ve acquired 7+ years of experience in medical device quality, supplier quality, or other regulated environments, with proven ownership of global QMS and/or large‑scale transformation initiatives. Experience leading cross‑functional programs and driving standardization, audit readiness, and enterprise‑level process improvements.
• You have strong expertise in Quality Management Systems (QMS) and Supplier Quality processes, including audits, supplier performance management (SPM), ASL, SCAR, and APQP. Demonstrated ability to operate in matrixed organizations, influence stakeholders, and leverage data‑driven decision‑making, with exposure to digital and AI‑enabled quality solutions preferred.
• You have a bachelor’s degree in engineering, Quality, Life Sciences, or a related field required;
  Master’s degree preferred.
• You have deep knowledge of regulatory standards (FDA, ISO 13485, MDSAP) and experience balancing compliance with innovation in a global environment. Proven leadership capabilities including strategic thinking, governance model development, change management, and the ability to drive global alignment and operational excellence.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

We believe that we are better together than apart. For our office‑based teams, this means working in‑person at least 3 days per week. Onsite roles require full‑time presence in the company’s facilities. Field roles are most effectively done outside the company’s main facilities, generally at the customers’ or suppliers’ locations.

The pay range for this position in Colorado Springs, CO, Latham, NY, Murrysville, PA, Nashville, TN, Orange Village, OH, and Reedsville, PA is $94,000 to $150,000.

The pay range for this position in Malvern, PA, and Plymouth, MN is $99,000 to $157,000.

The pay range for this position in…