PEGlobal are looking for a Complaint Analyst on behalf of our medical devices client on initially a 12 month contract based in their site in the West Yorkshire area
The Complaint Analyst is responsible for supporting the product complaint program including initial complaint assessment and identification of complaints related to adverse events.
The Complaint Analyst analyzes incoming product complaints, determines requirements for investigation, investigates and evaluates complaints, and finds solutions to customer issues by working interactively with cross functional teams.
Main Responsibilities of the role:
- 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.
Desired Experience and Background of the successful candidate
- 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.
- 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.
Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.Report this job