complaint analyst in leeds

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leeds, west yorkshire
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Are you an experienced Complaint Analyst? Are you looking to take on a new challenge with a Medical Devices Manufacturer? If so we are looking for individuals just like you!

We have an opportunity for a Complaint Analyst to join a leading client of ours, you would be responsible for supporting the product complaint program including initial complaint assessment and identification of complaints related to adverse events. The Complaint Analyst analyses incoming product complaints, determines requirements for investigation, investigates and evaluates complaints, and finds solutions to customer issues by working interactively with cross functional teams.

This is a contract opportunity for 12 months initially, working 37 hours per week Mon-Fri.

Responsibilities include:

* Collaborates with other groups such as engineering, clinical, regulatory, research and marketing to ensure a thorough and accurate complaint investigation
* Coordinates and participates in the evaluation of returned products
* Evaluates and confirms information from a technical perspective to ensure appropriate analysis, investigation, and that the root cause is documented prior to complaint closure
* Investigates and documents complaints
* Leads and supports the facility in identifying and eliminating compliance risks
* Partners with appropriate functional departments to achieve effective corrective action
* Prepares and/or reviews completed portions of regulatory submissions
* Reviews complaint files for accuracy and completeness
* Serves as a liaison between the quality assurance department and other departments to ensure timely and accurate completion of complaint investigations
* Summarizes results and makes suggestions for changes
* Prepares responses to customer inquiries regarding complaint investigations and prepares trend reports for complaints
* Under minimum supervision, the Complaint Analyst is responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and applicable standards
* This individual evaluates all information from a materials and technical perspective to ensure appropriate Root Cause analysis and investigation, and that any appropriate actions are undertaken and documented

Experience, qualifications and skills:

* A Technical Degree (BS or an equivalent) and/or a minimum of 2 years of 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 products or orthopaedic products and clinical applications of such products is preferred
* Work independently on routine tasks with high attention to detail
* 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
* Strong MS Excel skills , Good MS word skills and Good MS Powerpoint skills
* Good IT skills
* Experience of statistics an advantage
* Good data analysis skills
* Good written and oral communication skills

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.