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Job Title: Product Support Investigator
Location: Dundee
Pay rate: £12.83
Work days: Mon-Fri
Shift Pattern: 08:30 - 16:30

MAIN PURPOSE OF ROLE
● This is an individual contributor role with expectations aligned to the Capabilities and Behaviours as set out in the Client's Dundee Employee Handbook.
● 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 at Abbott Dundee.

MAIN RESPONSIBILITIES
● 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.
● Taking a self-motivated approach to continuous professional development and engaging with site training initiatives.
● Developing excellent relations with the department team and wider Operations group.
● Proposing ideas for new opportunities to improve communication and productivity.
● Being aware of the policies as set out in the Client's Employee Handbook and able to enact them as appropriate.

QUALIFICATIONS

Education

Education Level - Major/Field of Study Or Education Level
Degree Biological Sciences - 3 years practical experience in an IVD manufacturing environment

Experience/Background
● 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.
● Proficient with MS Word, Excel and Power-Point.
● Proficient with MS Word, Excel and Power-Point (preferred)Proficient with MS Word, Excel and Power-Point (preferred)
● Able to run IVD Tests; Immunoassay, Clinical Chemistry