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Manager, Customer Quality
FortiveCustomer Quality Manager leading complaint handling, surveillance, and field actions for ASP’s sterilization and disinfection solutions. Driving regulatory compliance, analytics, and sustained product quality improvements.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Customer Quality and Complaint Handling within the medical device industry, with a strong focus on post-market surveillance, regulatory compliance, and continuous improvement methodologies. Proven ability to lead cross-functional teams, drive accountability, and implement scalable quality systems.
Highest-signal resume keywords
Customer Quality ManagementComplaint HandlingPost-Market SurveillanceRoot Cause AnalysisRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Complaint HandlingPost-Market SurveillanceRoot Cause AnalysisRisk AssessmentData AnalyticsCAPAQuality ImprovementProcess StandardizationContinuous ImprovementMedical Device Reporting
Soft Skills
LeadershipCoachingCollaborationProblem-SolvingAccountability
Tools & Technologies
QMS WorkshopsKaizenVisual ManagementFBS ToolsQuality Dashboards
Industry Keywords
21 CFR Part 82021 CFR Part 80321 CFR Part 806ISO 13485ISO 14971EU MDRMDSAPHealth Authority ResponsesAudit ReadinessVigilance Evaluations
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Up to 30% domestic and international travel