Manager, Customer Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead, mentor, and enhance the global Customer Quality team tasked with managing complaint handling, post-market surveillance, field actions, failure analysis support, and customer defect tracking and resolution.

• Oversee the execution of complaint handling from intake to evaluation, investigation, documentation, closure, and escalation.

• Supervise high-risk complaint investigations, encompassing investigation strategy, technical evaluation, root cause analysis, risk assessment, and connections to escalation, CAPA, field action, or product quality enhancement.

• Collaborate with Regulatory Affairs, Medical Affairs, and Quality leadership on medical device reporting, vigilance evaluations, responses to health authorities, and maintaining inspection readiness.

• Coordinate Customer Quality initiatives for field actions, including escalation, completion tracking, closure readiness, and objective evidence collection.

• Direct post-market surveillance efforts, including data analytics, trend analysis, planning support, reporting, and escalation of emerging product quality or patient safety concerns.

• Own the mechanisms for tracking and resolving customer defects to transform quality signals into cross-functional actions and long-term product enhancements.

• Develop and oversee customer quality dashboards and reports, highlighting complaint performance, investigation aging, PMS trends, field action status, CDT&R, field failure rates, 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 processes.

• Ensure adherence to quality-system and regulatory requirements relating to complaint handling, post-market surveillance, medical device reporting support, field actions, CAPA linkage, audit readiness, and documentation.

• Collaborate globally and across functions 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 relevant technical discipline.

• At least 6 years of experience in Customer Quality, Product Quality, Complaint Handling, Post-Market Surveillance, Field Actions, CAPA, or a related quality function in the medical device industry.

• A minimum of 2 years of experience in a leadership or supervisory role over professional or technical employees, teams, or cross-functional quality workstreams.

• Capability to lead and develop both professional and technical teams while ensuring accountability for quality, timeliness, compliance, and lasting business outcomes.

• Strong understanding 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.

• Proficiency in applying risk-based thinking, root cause analysis, and problem-solving techniques.

• Experience in driving process standardization, continuous improvement, scalable operating models, QMS workshops, Kaizen events, standard work deployment, and the sustainment of process improvements.

• Ability to utilize analytics to identify complaint trends, emerging product risks, customer defect signals, field failure patterns, and performance gaps.

• Familiarity with 21 CFR Part 820, 21 CFR Part 803, 21 CFR Part 806, ISO 13485, ISO 14971, EU MDR, MDSAP, and relevant global post-market surveillance and vigilance requirements.

• Experience with quality systems in medical devices, pharmaceuticals, life sciences, or other regulated sectors.

• Experience in 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 various FBS tools.

• Willingness to travel domestically and internationally up to 30% of the time.

🏝️ Benefits

• Up to 30% domestic and international travel.