Location: Jacksonville, FL
Company: Johnson & Johnson Family Of Companies
encourage professionals and patients to proactively preserve and enhance sight for life. And in communities with the greatest need, we collaborate to expand access to quality eye care. The Customer Complaint Engineer will evaluate and document customer complaint investigations in accordance with company procedures and regulatory requirements.
The candidate will conduct product receiving, testing, investigations, updates, and file closure in JJV Complaint Handling System (CHS). The individual performing this role will build a strong network base with the technical teams / subject matter authorities, medical safety team and manufacturing sites to ensure appropriate complaint investigations.
Based on the complaint investigation results, determine if further investigation activities are required. The candidate will also maintain equipment calibration and preventive maintenance activities.
Performs laboratory equipment qualification and test method validation activities. Performs non-conformance and CAPA investigations related to Complaint Laboratory issues. Support internal & external audits including audit observations. Duties and Responsibilities: · Evaluates and investigates customer complaints for JJV product quality issues and concerns. · Reviews Device History Records (DHRs) and perform Complaint History Review (CHR). · Performs product receiving and testing, documents
result in CHS. · Document complaint investigations results in a timely manner following the applicable procedures.
· Determine if further investigation or escalation activities are required based on complaint investigation results. · Assists to identify corrective and preventative actions based on failure investigations root cause. · Partners with technical teams/subject matter authorities, medical safety team, manufacturing sites to ensure sound experimental design, effective data analysis, and subsequent closure of investigations. · For External Manufacturers complaints - perform initial evaluation, product testing and contact suppliers for complaint investigation activities, as applicable.
· Supports monthly complaint data, metrics, and identifies product quality trends as requested. · Provides interdepartmental feedback for investigation and resolution for product quality issues. · Performs equipment qualification, and test method validations. · Performs nonconformance and CAPA investigations related to Complaint Laboratory issues. · Support internal/external audits including Subject Matter Expert (SME) Complaint Laboratory representative, observation investigations, provide walkthrough tours, among others. Support Environment, Health, and Safety (EHS) requirements and compliance.
· Maintain preventive maintenance and calibration activities for laboratory equipment. · Identify, plan, and implement key projects to improve quality, reduce costs, increase efficiency, and improve cycle time by reducing wasted time, rework, etc. resulting in significant business improvement and customer satisfaction. · Develop procedures and documents (including test methods, job aids, guidelines, forms).
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