Investigates and processes product complaints, while maintaining compliance to all regulations- performs/document product history reviews and product evaluation properly and following gdp's.- maintain communication with engineering teams in order to review deeply complaints that may be related to a manufacturing and/or design issue.- devises new approaches to problems encountered and identifies process improvement opportunities.- perform measuring, testing and analysis on the returned devices to determine the root causes of the issues presented.
(e.g.
dimensional inspection with rule, caliper, laser micrometer, etc.
; also, perform functional testing by using pull testers, leak testers, and other equipment as required)- document the investigation in the applicable global complaint handling system applicable, following cordis politics and procedures, and as well as required per applicable regulations.- may be required to perform specialized studies such sem analysis, x-ray analysis, and others analyses as applicable.- comply with internal departmental metrics and with the complaint handling and safety surveillance departmental metrics.- address investigations to document audit observations, capa actions, non-conformances, and any other investigation as applicable.- participate in qa operation/management meetings to present complaint trending analysis per area as applicable and required typically as a leader of this activity.- maintain appropriate level of knowledge on product and processes manufactured by the company and oem's as required.- escalate manufacturing and design issues related properly and in a timely manner to investigate further on the failure found and to allow the implementation of the corrective/preventive actions detected during investigations.- responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies and procedures for health, safety and environmental compliance- work with complex projects to support improvement activities in the department.- supervise a small number of people to address departmental issues and provide guidance to the other team members.- perform complaint trending analysis and escalate as appropriate.- may be responsible to complete validation activities related to laboratory equipment.
*experience*:preferred- excellent written and oral english communication skills- problem solving skills is required.
- computer literate of ms word, ms powerpoint, ms excel a plus- ability to interact with individual/groups at all levels- ability to identify priorities and function independently- quality auditor certification is desirable (cqa)- analytical thinking- measurement systems knowledge.
*education*:required- bachelors or better in engineering or related field*behaviors*:required- detail oriented: capable of carrying out a given task with all details necessary to get the task done wellpreferred- team player: works well as a member of a group