Manager, Customer Quality

Advanced Sterilization Products is a global provider of sterilization and disinfection solutions for healthcare facilities. The Manager, Customer Quality leads the global Customer Quality team and oversees complaint handling, medical device reporting, field actions, post-market surveillance, customer defect resolution, and sustained product quality improvements.

Responsibilities:

• 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

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
• 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