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 well
preferred
- team player: works well as a member of a group