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 complianttimely 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 andin accordance withapplicable 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 ensuringappropriate investigationstrategy technical evaluation root cause analysis risk assessment and linkage to issue escalation CAPA field action or product quality improvement activities asrequired.

- 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 supporttimelycompletion 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 translatecomplaint service field failure and customer feedback signals into cross-functional action and sustained product quality improvements.

- Develop andmaintaincustomer 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 ofpoor 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

- Bachelors 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

-Demonstratedability 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 tocustomerfield 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 withabilitytoleverageanalytics toidentifycomplaint trends emerging product risks customer defect signals field failure patterns and performance gaps.

-Strong communicationskills 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 medicaldevicepharmaceutical life sciences or other regulatedindustry.

- 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.