Manager, Customer Quality

Job Title 

Manager, Customer Quality 

Job summary 

Leads the global Customer Quality team responsible for converting field signals into action and sustainment. The role ensures compliant, timely, and effective execution of complaint handling, medical device reporting, field action coordination, post-market surveillance, customer defect tracking and resolution, and sustainment of field quality improvements. 

Key Responsibilities 

Under minimal supervision, general direction, and in accordance with applicable government laws, regulations, and ASP policies, procedures, and guidelines, this position shall: 

• Lead, coach, and develop a team of customer quality professionals and technicians responsible for complaint handling, post-market surveillance, field actions, failure analysis support, and customer defect tracking and resolution. 

• Manage complaint handling execution, including intake, evaluation, investigation, documentation, closure, and escalation of reportable and non-reportable product complaints. 

• Oversee high-risk complaint investigations, ensuring appropriate investigation strategy, technical evaluation, root cause analysis, risk assessment, and linkage to issue escalation, CAPA, field action, or product quality improvement activities as required. 

• Partner with Regulatory Affairs, Medical Affairs, and Quality leadership to support medical device reporting, vigilance evaluations, health authority responses, and inspection readiness. 

• Coordinate Customer Quality activities related to field actions, including complaint-triggered escalation, field action completion tracking, closure readiness, and objective evidence to support timely completion and sustainment. 

• Lead post-market surveillance activities within Customer Quality scope, including data analytics, trending, planning support, reporting, and escalation of emerging product quality or patient safety signals. 

• Own customer defect tracking and resolution operating mechanisms to translate complaint, service, field failure, and customer feedback signals into cross-functional action and sustained product quality improvements. 

• Develop and maintain customer quality dashboards and reporting to enable data-driven decision making, including complaint performance, investigation aging, PMS trends, field action status, CDT&R, field failure rate, Paynter charts, and sustainment metrics. 

• Implement scalable operating mechanisms, including standard work, risk-based work tiering, automation, visual management, QMS workshops, Kaizen activities, and structured follow-up to improve efficiency, strengthen compliance, and reduce cost of poor quality. 

• Ensure compliance with quality system requirements and regulatory expectations for complaint handling, post-market surveillance, medical device reporting support, field action coordination, CAPA linkage, audit readiness, and robust documentation practices. 

• Collaborate globally and cross-functionally with RAQA, R&D, IT, Operations, Manufacturing, Supplier Quality, and regional teams to ensure clear interfaces, effective handoffs, alignment on quality priorities, and sustained execution of improvement initiatives.

Education and Experience Requirements 

• Bachelor’s degree (or equivalent experience) in Engineering, Quality, Life Sciences, Health Sciences, Nursing, Biology, Chemistry, Public Health, or related technical discipline. 

• Minimum 6 years of experience in Customer Quality, Product Quality, Complaint Handling, Post-Market Surveillance, Field Actions, CAPA, or 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.

Role and Competencies Requirements 

- Demonstrated 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 to customer, field, technical, operational, and compliance quality challenges. 

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

• Data-driven mindset with ability to leverage analytics to identify complaint trends, emerging product risks, customer defect signals, field failure patterns, and performance gaps.

- Strong communication skills to convey expectations, present quality risks, escalate issues, align cross-functional stakeholders, and guide teams through competing priorities. 

• 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 other regulated industry. 

• Experience supporting regulatory compliance inspections and audits related to complaint handling, post-market surveillance, field actions, CAPA, and quality system processes. 

• Process excellence tools/methodologies (Six Sigma, FBS, root cause analysis, visual management, standard work, etc.). 

• Good working knowledge of several FBS tools. 

• Up to 30% of Travel: Domestic and International.