Manager, Customer Quality

Job not on LinkedIn

🕒 August 17

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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Fortive

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2016

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

💰 Post-IPO Equity on 2020-03

Healthcare • Manufacturing • Logistics

Fortive is a global industrial technology company that specializes in delivering advanced healthcare solutions, intelligent operating solutions, and precision technologies. With a team of 18,000 employees, Fortive works on solving tough technical challenges, empowering safer, smarter, and more efficient industrial operations. The company emphasizes sustainability, integrity, and continuous improvement, striving for a future that's stronger, safer, and smarter. Fortive has been recognized as one of America's Most Responsible Companies, demonstrating its commitment to positive social and environmental impact.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• Up to 30% domestic and international travel