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Marketed Product Support Engineer
Our client is a leader in their industry and they have an opportunity for a Marketed Product Support Engineer to join their team.
The successful candidate will drive product safety from customer complaint feedback by providing guidance within the Product Safety group on technical aspects relating to complaint evaluations and investigations. It will also be required to perform and document analysis of complaint samples and document complaint evaluation and complete complaint investigation.
It will be required to work with R&D, Metrology; Tooling and Production in the case of complaint evaluation and investigations to plan appropriate test selection/design of testing/CAPA. Also to represent the MPS team where Supplier interaction is required to discuss technical elements of investigations and proposed CAPA by Suppliers.
- To provide guidance to MPS team and Risk Management team within the Product Safety group on technical aspects of product evaluation,
- test selection and test result analysis and any general technical input required during the day to day running of the MPS department.
- To follow Complaints procedures in logging and investigating complaints including device evaluation/testing as required.
- To work with Associates in Production and Design (or other relevant Subject Matter Experts) guiding the creation of analytical fact-based
- documented investigations and to produce reports, in accordance with the complaint handling and investigation procedures.
- To provide an impartial review of probable and actual root causes presented in investigation reports by subject matter experts to ensure
- that the corrective and preventive actions address the needs of the patient in resolving any failure.
- To work with other departments to ensure that all potential failures that are identified during the course of investigations are correctly
- documented following Exception procedures.
- To provide input into Risk Management Files and Clinical Evaluations and Post Market Surveillance sessions and reports.
- To review reports/work of other MPS team members as required by the MPS Team Leader.
- To perform trend analyses on reported complaints and report findings to management to support an early warning alert system for emerging
- trends to support corrective actions.
- To participate in FMEA meetings as required.
- To represent the company in meetings and calls with customers and provide complaint status updates verbally or via power point
- presentation as required by the MPS Team Leader or Product Safety Manager.
- To communicate effectively with line managers and senior/Executive /management on incoming complaints and
- investigation progress.
- In the course of investiqations visit suppliers and customer production
- sites in order to understand processes and agree appropriate CAPAs as required.
- Experience working with technical drawings/metrology review
- Highly computer literate (Word, Excel and Powerpoint)
- Proven track record of writing technical investigation reports in medical device/pharmaceutical industry
- Educated to degree level, preferably in an engineering or technical/science subject
Matchtech acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers and is part of Gattaca Plc.
Gattaca Plc provides support services to Matchtech and may assist with processing your application.
You can not apply for this job as its status is Closed.
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