Team Lead, Complaint Investigation Lab

Position Summary

Principal Responsibilities

Individual supports the Product Quality Assurance Team(s) and manufacturing sites with all matters related to complaint sample processing and complaint investigations; Leads team activities and personnel related to complaint sample processing and complaint investigations performed in the Kulim complaint investigation laboratory.

•    Oversees complaint investigations and other laboratory functions performed in the Kulim complaint laboratory to ensure quality and timeliness for Regulatory reporting.
•    Oversees complaint sample processing and associated personnel to maximize efficiencies and integrity of complaint samples. 
•    Maximizes complaint sample through-put and complaint investigation timeliness and documents associated processes.
•    Interfaces with a variety of internal and external customers including: Global Operations, Manufacturing, Marketing, Research & Development, and Regulatory.
•    Documents laboratory and complaint investigation processes according to established guidelines.
•    Uses Teleflex ERP system to perform complaint trend analysis, and to update complaint investigation(s).
•    Notifies manufacturing site(s) of any potential manufacturing issue as a result of a reported complaint.
•    Coordinates investigations requiring more in-depth testing with Research & Development. 
•    Reviews and updates departmental procedures and work instructions. 
•    Supervises laboratory Quality Engineering personnel performing complaint investigations.
•    Perform other duties as assigned or necessitated by business conditions or changes.
 

Education / Experience Requirements

•    B.S. Degree or equivalent work experience.
•    3-5 years of experience performing root cause analysis of technical discrepancies, abnormalities, and product non-conformances.
•    3-5 years of experience preparing laboratory documentation (laboratory procedures, analysis spreadsheets, reference documents, and others).
•    3-5 years of experience working in a regulated environment
 

Specialized Skills / Other Requirements

•    Excellent use of grammar and writing skills.
•    Ability to multi-task.
•    Experience utilizing ERP system like SAP
•    Experience utilizing complaint management system.
•    Displays a positive attitude as a Customer Advocate for Teleflex, Inc.
•    Successfully managed integration of new product introduction or newly acquired products as lead investigator.
•    Considerable and invaluable product knowledge gained through training and experience.
•    Often noted by customers and sales staff as providing superior service.
•    Often seeks additional work outside the scope of daily responsibilities.
•    Participates in or leads departmental initiatives/objectives outside the scope of daily responsibilities.
•    Participates in regulatory inspections, ISO audits, or corporate audits.
•    Consistently performs at a high level for the department.