Medical Device Investigator - Leamington Spa

Leamington Spa
02 Jan 2019
30 Jan 2019
Contract Type
CK Group is recruiting for a Medical Device Investigator to join a company in the Pharmaceutical industry at their site based in Leamington Spa on a contract basis for 12 months.

The Company:
Our client is a British multinational medical equipment manufacturing company, an international producer of advanced wound management products, trauma and clinical therapy products and orthopaedic reconstruction products. Its products are sold in over 120 countries.

This role is located in Leamington Spa, an attractive spa town notable for its Regency architecture and parks. Leamington serves primarily as a commuter town for Coventry and Birmingham. Approximately 22 miles to Coventry and 37 miles to Birmingham.

The Role:
The Medical Device Investigator will perform the investigation on customer complaints with and without products returned and is responsible to evaluate and document the root cause of the failure and document the complaint analysis under the elements of the Quality Management System. This position requires understanding of products at site and various failure modes associated with these products. The Investigator must effectively communicate the results of an investigative analysis through written reports. The work should be in compliance with all appropriate laws and regulations, relevant to the job function.

Role involves:
- Performing investigations to identify the root cause of alleged product failure and accurately documenting the analysis in the complaints system. Failure investigation may include visual and photographic assessment of product condition, functional testing or the disassembly of returned device(s) in order to isolate the source of failure and make a definitive root cause analysis.
- Analysing data and drawing conclusions based upon the available information from the investigation and documenting findings (including medical investigations) in reports in the complaint handling system in an applicable manner for the customer completed in a timely manner.
- Conducting and controlling shipping logistics of sending and receiving parts to and from the supplier respectively, and also to internal sites for further evaluations. Receiving information from the supplier and updating the complaint handling system with the information. Working with suppliers for timely completion of investigations and other action items assigned to them.
- Working closely with medical advisor(s) and medical investigation team to quantify risk.
- Supporting legal department as required.
- Acting as point of contact for Research & Development, Marketing, Logistics, Regulatory Affairs, Quality, Operations and external bodies such as appointed experts in their support of investigations related to the complaint management process.
- Providing updates on complaint investigation status.
- Generating signals for containment and communicating with appropriate personnel on site to request corrective and preventive measures in cooperation with the Quality department through the CAPA system, as necessary.
- Supporting Health Hazard Evaluation for suspected adverse incidents.

Your Background:
The ideal candidate for this role will have:
- Minimum of 5 years of work experience in a technical field OR 2 years of work experience with HND with demonstration of capabilities preferably in the medical device industry OR no work experience is required for candidate with a degree or similar qualification in a technical field.
- Understanding of basic inspection techniques and problem solving skills needed.
- Experience working in FDA, GMP and ISO environments preferred.
- Proficient in Word and Excel, and good writing skill is required.
- Experience in MS Access, MS Visio, Agile, and SAP desirable.

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 KA44005 in all correspondence