Manager, Customer Quality

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🕒 Agosto 17

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

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Fortive

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2016

🏥 Saúde

🏭 Manufatura

📦 Logística

💰 Post-IPO Equity em 2020-03

Healthcare • Manufacturing • Logistics

A Fortive é uma empresa global de tecnologia industrial que se especializa em oferecer soluções avançadas para a área da saúde, soluções operacionais inteligentes e tecnologias de precisão. Com uma equipe de 18. 000 colaboradores, a Fortive trabalha para resolver desafios técnicos complexos, promovendo operações industriais mais seguras, inteligentes e eficientes. A empresa enfatiza sustentabilidade, integridade e melhoria contínua, buscando um futuro mais forte, mais seguro e mais inteligente. A Fortive foi reconhecida como uma das empresas mais responsáveis dos Estados Unidos, demonstrando seu compromisso com impacto social e ambiental positivo.

Descrição

• Lead, coach, and develop the global Customer Quality team responsible for complaint handling, post-market surveillance, field actions, failure analysis support, and customer defect tracking and resolution • Manage complaint handling execution from intake through evaluation, investigation, documentation, closure, and escalation • Oversee high-risk complaint investigations, including investigation strategy, technical evaluation, root cause analysis, risk assessment, and linkage to escalation, CAPA, field action, or product quality improvement • Partner with Regulatory Affairs, Medical Affairs, and Quality leadership on medical device reporting, vigilance evaluations, health authority responses, and inspection readiness • Coordinate Customer Quality activities for field actions, including escalation, completion tracking, closure readiness, and objective evidence • Lead post-market surveillance activities, including data analytics, trending, planning support, reporting, and escalation of emerging product quality or patient safety signals • Own customer defect tracking and resolution mechanisms to convert quality signals into cross-functional action and sustained product improvements • Develop and maintain customer quality dashboards and reporting covering complaint performance, investigation aging, PMS trends, field action status, CDT&R, field failure rate, Paynter charts, and sustainment metrics • Implement scalable operating mechanisms such as standard work, risk-based work tiering, automation, visual management, QMS workshops, Kaizen activities, and structured follow-up • Ensure compliance with quality-system and regulatory requirements for complaint handling, post-market surveillance, medical device reporting support, field actions, CAPA linkage, audit readiness, and documentation • Collaborate globally and cross-functionally with RAQA, R&D, IT, Operations, Manufacturing, Supplier Quality, and regional teams

🎯 Requisitos

• Bachelor’s degree or equivalent experience in Engineering, Quality, Life Sciences, Health Sciences, Nursing, Biology, Chemistry, Public Health, or a related technical discipline • Minimum 6 years of experience in Customer Quality, Product Quality, Complaint Handling, Post-Market Surveillance, Field Actions, CAPA, or a related quality function within the medical device industry • Minimum 2 years of experience leading or supervising professional employees, technical employees, teams, or cross-functional quality workstreams • Ability to lead and develop professional and technical teams while driving accountability for quality, timeliness, compliance, and sustained business results • Strong working knowledge of complaint handling, high-risk complaint investigations, medical device reporting/vigilance support, post-market surveillance, field actions, CAPA, customer quality, and product quality improvement processes • Ability to apply risk-based thinking, root cause analysis, and problem-solving • Experience driving process standardization, continuous improvement, scalable operating models, QMS workshops, Kaizen events, standard work deployment, and process-improvement sustainment • Ability to leverage analytics to identify complaint trends, emerging product risks, customer defect signals, field failure patterns, and performance gaps • Knowledge of 21 CFR Part 820, 21 CFR Part 803, 21 CFR Part 806, ISO 13485, ISO 14971, EU MDR, MDSAP, and applicable global post-market surveillance and vigilance expectations • Experience in quality systems within medical device, pharmaceutical, life sciences, or another regulated industry • Experience supporting regulatory compliance inspections and audits related to complaint handling, post-market surveillance, field actions, CAPA, and quality-system processes • Knowledge of process excellence tools/methodologies, including Six Sigma, FBS, root cause analysis, visual management, and standard work • Good working knowledge of several FBS tools • Up to 30% domestic and international travel

🏖️ Benefícios

• Up to 30% domestic and international travel