Job Purpose and primary objectives:
* Exciting opportunity for a QA Analyst/Vigilance professional to join customer's team in Dublin.
* The successful candidate is responsible for complaint handling including Vigilance activities associated with project products.
Key responsibilities:
* Intakes, evaluates, codes and analyzes complaints associated with the project products.
* Corresponds with customers by following up on complaint details and also provides customer updates regarding the results of inquiries and analysis of products.
* Uses discretion in escalating unusual product performance issues, collaborates with engineering, resolves customer complaints.
* Supports Vigilance activities with EMEA Competent Authorities Participates in product improvement, field failure analysis and other analytical teams responsible for the improvement of products and regulatory issues.
* This position requires a very high degree of organization skills, attention to details, ability to multi-task, technical competence and communicative ability in order to receive, evaluate, investigate and respond to customers' questions and complaints.
* Interfaces with all levels of health care professionals (doctors, nurses, biomedical technicians and purchasing agents, materials managers and risk managers) to document, investigate, and correct field-related problems.
* Communicates customer concerns and complaints to individuals who manage databases and analyze data to identify trends, needs for product and service enhancements and communicate the findings with relevant individuals such as R&D engineers, business unit managers, and other personnel to communicate the findings.
* Performs product complaint documentation, investigation, customer response, and consulting activities oncustomer products and authors correspondence to customers addressing complaint investigations.
Key Skills/Knowledge:
* Previous experience in Medical Device and/or Pharmaceutical industry in QA/RA preferable, however not required
* Studies in medical, pharma or engineering preferable Customer support experience preferred.
* Ability to read, write and speak fluent German and/or French is required
* Fluency in English is required.
Experience required:
* Strong PC/Data Entry Skills required
* A high degree of interpersonal relations skills
* Strong verbal and written communication skills
* Problem solving
* Must be able to work under pressure
* Must be able to maintain a high degree of accuracy and analytical thinking
* Must be able to deal effectively with problems
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