Product Support Investigator

We are seeking a Product Support Investigator I to join our Quality Assurance team in Dundee. This is an individual contributor role with expectations aligned to the Capabilities and Behaviours set out in the Abbott Dundee Employee Handbook.

Working as part of the Product Support Team the Product Support Investigator is primarily responsible for logging end-user complaints assessing adverse event reportability and conducting investigations of product deficiencies. The role also supports quality systems compliance activities and continuous improvement initiatives across the site.

Key Responsibilities

• Log acknowledge and assess all alleged product deficiencies received from end users for adverse event reportability in accordance with timelines specified by site procedures.

• Investigate product complaints establish root cause and report findings.

• Log acknowledge investigate and report outputs of Supplier Corrective Actions (SCARs).

• Execute site on-market stability and proficiency scheme programmes.

• Provide administrative support to the Nonconformance and CAPA systems including impact assessment activities.

• Perform archiving activities for Device History Records in line with record retention policies maintaining both on-site and off-site archive records.

• Support the Management Operating System by attending and participating in Tier Review Meetings to track team progress on a daily basis.

• Take full accountability for personal workload ensuring all work is completed to a high standard and in accordance with site policies procedures and applicable regulations.

• Proactively contribute to continuous improvement initiatives and general housekeeping duties.

• Take a self-motivated approach to continuous professional development and actively engage with site training initiatives.

• Develop excellent working relationships within the department and across the wider Operations group.

• Propose ideas for opportunities to improve communication and productivity.

• Maintain awareness of policies contained within the Abbott Dundee Employee Handbook.

• Carry out other duties as requested by the Line Manager and/or Department Manager.

Required Qualifications

• Degree or equivalent qualification preferably in a Life Sciences discipline; and/or

• Relevant experience within the life sciences industry or another similarly regulated industry.

Skills & Experience

Successful candidates will ideally possess:

• Ability to run IVD tests including Immunoassay and Clinical Chemistry.

• Strong attention to detail.

• Excellent organisation and time management skills.

• Good written and verbal communication skills.

• Ability to work flexibly and collaboratively as part of a small team.

• Practical understanding of complaint logging and investigation of IVD Product Deficiencies in accordance with ISO 13485:2016 for the Design and Manufacture of In-Vitro Diagnostics (preferred).

• Experience using complaint management software preferably Salesforce (SFDC).

• Ability to utilise Root Cause Analysis (RCA) tools including A3 and DMAIC methodologies.

• Capability to contribute to and perform Risk Assessments Risk Management/Control activities and Failure Mode Effects Analysis (FMEA).

• Experience with Enterprise Resource Planning (ERP) systems.

• Experience with Electronic Document Management Systems (EDMS).

• Experience with CAPA systems preferably Agile.

• Proficiency in Microsoft Word Excel and PowerPoint.

What Were Looking For

Were looking for a motivated detail-oriented individual who thrives in a regulated environment and is committed to delivering high-quality work. You will be a strong team player with a continuous improvement mindset excellent organisational skills and the ability to effectively investigate and resolve product quality concerns while supporting compliance with applicable regulatory requirements.