Role Overview :
This position supports the complaint investigation process. This position will perform required investigation tasks based on complaint criticality and in accordance with procedure requirements and document the results in an electronic complaint management system.
Different sources of information will be used to conduct required assessment and the results will be documented in the complaint eQMS.
The individual in this role is accountable for completing work tasks in accordance with policies and procedures. The position has to be able to work with other departments and teams.
90%) Perform medical device complaint investigations, including the following :
Continually track open and in process device complaint investigations
Support complaint investigations conducting and documenting required tasks such as : Manufacturing record review, risk documentation review, complaint history review, device specification and labeling review
Document the results and conclusions of the investigation in accordance with policies and procedures within the complaint management system
Ensure that the depth of the investigation is commensurate with the criticality of the complaint
Provide documented evidence of investigation and any conclusions established as a result of the investigation actions
Complete all required customer complaint investigations in an accurate, professional and timely manner.
10%) Other activities as defined by management
Education Requirements :
Bachelor degree in engineering, biology or other related discipline.
Technical training and experience on related fields or equivalent.
Minimum Experience :
At least 1 year of relevant experience (preferred).
Regulatory knowledge of complaint handling; complaint investigation and / or quality systems (beneficial).
1 year of experience in the field of Quality Assurance and / or Compliance in a regulated environment (preferred).
Basic knowledge of regulatory compliance requirements (, GMP, 21 CFR 820, ISO 13485) as well as quality assurance principles and practices.
Must be fluent in English language, verbal and written (advance level).
Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
Ability to work with a diverse network of both internal and external groups and / or individuals.
Must have ability to work in a team environment and be organized.
Excellent interpersonal & communication skills, both written and verbal.
Ability to interpret diverse regulations and drive / influence effective implementation.
Must be able to read specifications.
Requires excellent verbal and written communication skills and the ability to work with minimal supervision.
Ability to work in an international environment.
Strong feeling for Accountability.
Experience with utilization of Pilgrim, TrackWise or ETQ preferred