The main responsibilities of will be to:
Support the product complaint program including initial complaint assessment and identification of complaints related to adverse events.
Analyse incoming product complaints, determine requirements for investigation, investigate and evaluate complaints and find solutions to customer issues by working interactively with cross functional teams.
Collaborate with other groups such as engineering, clinical, regulatory, research and marketing to ensure a thorough and accurate complaint investigation.
Coordinate and participate in the evaluation of returned products.
Evaluate and confirm information from a technical perspective to ensure appropriate analysis, investigation and that the root cause is documented prior to complaint closure; investigate and document complaints.
Lead and support the facility in identifying and eliminating compliance risks.
Partner with appropriate functional departments to achieve effective corrective action and prepare and/or review completed portions of regulatory submissions.
Review complaint files for accuracy and completeness and serve as a liaison between the quality assurance department and other departments to ensure timely and accurate completion of complaint investigations.
As a Complaint Analyst you will have the following qualifications, skills and experience:
A Technical Degree (BS or an equivalent) and experience in a medical device industry, preferably in orthopaedics or another industry regulated by the European Medical Devices Directive or US FDA.
Experience in failure analysis and material science is preferred and prior experience working directly with Complaint Investigations is an asset.
An advanced degree in a related discipline and/or further training or certificates (especially medical or statistical) is also an asset.
A broad knowledge of orthopaedic products and clinical applications of such products is preferred.
The successful candidate must be able to work independently on routine tasks with high attention to detail.
The individual must have good communication skills, the ability to multi-task, strong organizational skills, and thrive on deadlines.
Six Sigma experience, knowledge of Process Excellence tools and/or Oracle Databases is preferred.
Proficiency in the Microsoft Office suite of products is required. Strong oral and written English communication skills are required, and fast keyboarding is essential.
An ability to work cross functionally and promote good working relationships with other teams, to determine priorities, state challenges productively and solve problems is required.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA41729 in all correspondence.
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