Quality Assurance Manager

Schedule: Monday through Friday | Flexible start between 8:00–9:00 AM | 40–50 hours per week (overtime as needed)

We are seeking an accomplished and forward‑thinking Quality Assurance Manager to lead quality operations across our Americas Fulfillment Network. This highly visible leadership role is responsible for implementing, maintaining, and continuously improving a robust Quality Management System (QMS) within a multi‑site, regulated environment.

Reporting to the Global Quality function, you will serve as a strategic partner to Operations, Transportation, Global Trade, Regulatory, and Corporate Quality teams. You will play a critical role in driving operational alignment with ISO 13485, EU MDR, and other global regulatory requirements while fostering a culture of compliance, accountability, and continuous improvement across fulfillment sites in Moreno Valley, Atlanta, and Indianapolis.

• Lead cross‑functional collaboration between Operations, Transportation, Regulatory, and Quality teams to ensure sustained compliance with ISO 13485 across multiple fulfillment sites.
• Deliver clear quality performance insights, risk trends, and strategic recommendations to senior leadership and cross‑regional stakeholders.
• Partner with 3PL providers and internal supply chain teams to standardize quality workflows, improve service levels, and reduce compliance gaps.
• Champion a quality‑first culture by coaching leaders, reinforcing expectations, and embedding best practices into daily operations.
• Manage complex stakeholder priorities, ensuring timely investigation and resolution of systemic issues impacting delivery, cost, and compliance.

• Develop and execute a multi‑site Quality strategy aligning global QMS standards with regional operational requirements.
• Assess fulfillment and logistics processes to identify gaps and implement multi‑year roadmaps that improve audit readiness, reduce defects, and enhance efficiency.
• Translate business objectives into actionable quality initiatives that support growth, cost reduction, and regulatory compliance.
• Modernize QMS elements through simplification, digital transformation, and automation initiatives.
• Serve as a strategic thought partner to Operations and Supply Chain leaders, enabling data‑driven decision‑making and risk prioritization.
• Lead internal, external, and regulatory audit preparation and execution across multiple sites.

• Apply strong knowledge of fulfillment, distribution center operations, logistics, and transportation workflows within a regulated industry.
• Prioritize and allocate Quality resources to support business objectives related to delivery, cost, and compliance.
• Lead process improvement and standardization initiatives across teams with varying levels of process maturity.
• Streamline and modernize quality processes through innovative solutions, automation, and digital tools.
• Deliver regular quality performance updates and strategic risk assessments to senior leadership.

• Implement AI‑driven or predictive models to proactively identify quality risks and optimize resource allocation across distribution centers.
• Enable automated tools to streamline QMS documentation, complaint and nonconformance triage, and investigation workflows.
• Leverage advanced analytics to identify root‑cause trends, optimize workflows, and improve decision‑making accuracy.
• Introduce automation solutions that reduce manual touchpoints and improve process standardization.

• Bachelor’s degree in Engineering, Science, Operations, or a related technical discipline.
• Minimum 7+ years of experience leading quality professionals within a multi‑site or matrixed fulfillment environment.
• Demonstrated success implementing and sustaining ISO 13485 or equivalent QMS frameworks.
• Hands‑on leadership experience managing nonconformances, CAPA, on‑hold inventory, investigations, and structured problem‑solving methodologies (A3, 8D, DMAIC).
• Experience preparing for and leading internal, external, and regulatory audits.
• Proven ability to drive change, influence…