Job Title
Product Support Investigator
Dundee, Scotland
Fixed-Term Contract: 12 Months (Initially)
About the Role
Entrust Resource Solutions is partnering with a Medical Device client in Dundee to recruit a Product Support Investigator.
This role forms part of the Product Support Team and involves logging, assessing, and investigating end-user complaints.
Key Responsibilities
* Logging, acknowledging, and assessing alleged product deficiencies for adverse event reportability within specified timelines.
* Investigating causes and reporting findings.
* Managing Supplier Corrective Actions (SCARS) and ensuring compliance with site policies and regulations.
* Contributing to continuous improvement initiatives and general housekeeping duties.
Requirements
* At least 3 years' experience in the life sciences or a similarly regulated industry (In-vitro Diagnostics preferred).
* A practical understanding of complaint logging and investigation according to ISO 13485:2016 guidelines for In-vitro Diagnostics (preferred).
* Experience with complaint management software (SFDC preferred).
* Proficiency in Root Cause Analysis tools, including A3/DMAIC.
* Ability to contribute to and perform Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA).
* Experience with Enterprise Resource Planning Systems (ERP) and Electronic Document Management Systems (EDMS).
* Experience with CAPA systems (Agile preferred).
* $65,000 - $75,000 per annum (dependent on experience).
What We Offer
A competitive salary and benefits package. The opportunity to work with a leading medical device company and contribute to their success.