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Product Support Investigator
Dundee
12 months (initially)

Entrust Resource Solutions are supporting their Medical Device client in Dundee with their search for a Product Support Investigator

Working as part of the Product Support Team, the Product Support Investigator II is primarily responsible for the logging, assessing the reportability of end user complaints and subsequent investigation.

Key Responsibilities:

Log, acknowledge and assess all alleged product deficiencies received from end users for adverse event reportability to time lines specified by site procedures
Log, acknowledge and assess all alleged product deficiencies received from end users for adverse event reportability to time lines specified by site procedures.
Investigate, establish and report cause
Log, acknowledge Supplier Corrective Actions (SCARS) received Taking full accountability for personal workload, ensuring work is completed to a high standard in accordance with site policies, procedures and applicable regulations
Proactively contributing to continuous improvement initiatives and other general housekeeping duties What do we need from you?

3 years experience within the life sciences or similarly regulated industry (In-vitro Diagnostics preferred)
A practical understanding of complaint logging and investigation of IVD Product Deficiencies per ISO 13485:2016 for the Design and Manufacture of In-vitro Diagnostics (preferred)
Experience with complaint management software; SFDC prefered
An ability to employ state-of-the-art Root Cause Analysis (RCA) tools, including A3/DMAIC.
The capability to contribute to and perform Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA).
Experience with an Enterprise Resource Planning System (ERP)
Experience with Electronic Document Management Systems (EDMS)
Experience with CAPA systems – Agile preferred
To find out more about this opportunity, please contact Lynsey today on (phone number removed) or send an up to date copy of your CV to (url removed)