Manager, Customer Quality

Emploi pas sur LinkedIn

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 11%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Fortive

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 2016

🏥 Santé

🏭 Fabrication

📦 Logistique

💰 Post-IPO Equity en 2020-03

Healthcare • Manufacturing • Logistics

Fortive est un groupe mondial de technologies industrielles, spécialisé dans la fourniture de solutions avancées pour la santé, de solutions d’exploitation intelligentes et de technologies de précision. Fort de 18 000 collaborateurs, Fortive s’attaque à des défis techniques complexes afin de rendre les opérations industrielles plus sûres, plus intelligentes et plus efficaces. L’entreprise met l’accent sur la durabilité, l’intégrité et l’amélioration continue, en œuvrant pour un avenir plus robuste, plus sûr et plus intelligent. Fortive a été reconnue comme l’une des entreprises les plus responsables des États‑Unis, démontrant son engagement en faveur d’un impact social et environnemental positif.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• Up to 30% domestic and international travel