Our Client is a Developing Healthcare comany based in the West of Ireland. They are offering the right candidate a 1 year contract to further develop the Complaint Handling division.
As a Complaint Handling Specialist you will need to demonstrate working knowledge of the following:
Problem Solving:
• Processing, investigation, classification and trending of customer complaints
•Ensuring that all complaints are properly investigated in accordance with OLMEI procedures and FDA/ISO requirements
•Provision of a timely and satisfactory response to customer complaints
•Liaison with Manufacturing, CSU, Technical, Logistics and other in house groups to determine root cause and solve issues
•Experimental design and/or performance of hands-on laboratory studies to aid in problem resolution
•Communication of problem resolutions and/or investigation outcomes to all appropriate personnel
Maintenance of Documentation/GMP:
•Ensuring that confirmed complaints or reportable events are escalated to the appropriate personnel in a timely manner.
•Issuing of clear reports concerning investigations to internal and external groups
•Ensuring complaint reports are complaint from a regulatory stance
•Execution of routine lab/office maintenance duties as required
Customer Focus:
•Maintaining a good professional relationship with customers of OLMEI
•Ensuring that investigations are aligned with customer expectations and that satisfaction with OLMEI products/services is maintained
Your profile:
- Educated to Degree level or equivalent in a Science related discipline
- At least 2 years experience in a QA role, ideally Medical Device/ similar laboratory / complaint handling environment in a healthcare company
- Good knowledge of FDA QSR and ISO13485 requirements
- Needs to show problem solving, report and investigations and excellent communication. For
For further information contact Catherine on 091- 563 868 or email cduggan@sigmar.ie
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