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Quality Assurance Manager

Suna Solutions

Schedule: Monday through Friday | Flexible start between 8:00–9:00 AM | 40–50 hours per week (overtime as needed) Overview 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. Key Responsibilities Leadership & Culture 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. Quality Systems & 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. Operational Excellence & Innovation 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. Analytics, Automation & AI 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. Qualifications & Experience 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 cross‑functional stakeholders, and prioritize effectively in complex environments. Strong written and verbal communication skills with experience presenting to senior leadership. Preferred Qualifications Experience working within global or multi‑regional organizations. Lean or Six Sigma certification. Experience influencing remote and cross‑regional teams. Experience deploying digital forms, automated workflows, predictive analytics, or advanced reporting tools in quality operations. Demonstrated success leading digital transformation initiatives within regulated settings. Strategic thinker with a hands‑on execution mindset Collaborative leader with strong interpersonal skills Highly organized with exceptional attention to detail Passionate about continuous improvement and operational excellence Resilient, adaptable, and solution‑oriented This role supports multi‑site 3PL operations, providing quality oversight across fulfillment centers in Moreno Valley, Atlanta, and Indianapolis, with primary onsite presence in Lithia Springs, Georgia. If you are a quality leader who thrives in complex, regulated environments and is energized by building scalable systems that drive operational excellence, we encourage you to apply. EQUAL EMPLOYMENT OPPORTUNITY STATEMENT Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws. REQUESTING AN ACCOMODATION Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired. If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at View phone number on click.appcast.io, send us an email or speak with your recruiter. PAY TRANSPARENCY POLICY STATEMENT Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington. #J-18808-Ljbffr

Vacancy posted 1 day ago
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