Review customer complaint work orders, maintaining communication with the Customer Care Solutions Center and Field Service Engineers to ensure the required information is obtained.
To identify potential FDA reportable safety events that must be submitted timely to the appropriate factory for further investigation.
Since the FDA considers every call for service to be a complaint our goal is to review every corrective maintenance service call for 2 reasons :
1)To ensure a quality record, meaning that all the data elements are present in the record. We use the 12 data elements as our main guide to ensure we have accurate and complete information.
2)To do an assessment of hazard or harm using the information contained within the record. This is to determine if this issue has harmed a patient or user or if it likely to cause or contribute to death or serious injury to a patient or user if it recurs.
You are responsible for
Review all Imaging Systems Corrective Maintenance orders, to ensure a complete quality service record.
We’re the first level reviewers for the factories catching cases that could potentially go unnoticed to ensure FDA and Quality & Regulatory regulations are met and keep the company within compliance.
Interface with Field Service Engineers, Remote Service Engineers and Frontline to obtain updates to ensure a complete quality service record
Review all Imaging Systems Corrective Maintenance work-orders for symptom coding to identify potential product reportable complaints.
Escalate identified product reportable complaints to the factories through TrackWise (Post Market Surveillance Complaint Handling System).
As we review every case, it is our responsibility to submit cases for the factories review, including cases where the patient / user was injured, cases converted to a complaint by Remote Service Engineers / Field Service Engineers, and cases that are on our escalation list.
If a case is deemed potentially reportable by the factory's Quality & Regulatory and converted to a complaint, the factory's Quality & Regulatory Complaint Investigators take over the investigation.
You are a part of
The team performing assessment of hazard or harm using the information contained within the record. This is to determine if this issue has harmed a patient or user or if it likely to cause or contribute to death or serious injury to a patient or user if it recurs.
To succeed in this role, you should have the following skills and experience
English (Advanced) - Mandatory
Portuguese (Intermediate) Preferable, not mandatory
Good clear and concise oral and written communications skills.
Organization, time management and presentation skills
Intermediate skills in using MS Windows, Office (e.g., Word, Excel), Basic skills of SAP MP1 and Salesforce.
2 years of experience in an administrative position with experience in a similar documentation / data driven position. Preferable, not mandatory
Familiar with FDA regulations including FDA CFR : 820.803, 820.100 and 820.198, and 820.200. Preferable, not mandatory
Well versed in Q&R medical device terminology.
In return, we offer you
A unique opportunity to develop new skills and absorb knowledge regarding the Health Industry in an environment where growing will make you help connect with your purpose.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 2.
5 billion lives a year by delivering innovative solutions across the . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.