Product Support Investigator

Randstad Business Support - London; Dundee; On-site; Full time

Job summary

Join a forward-thinking company as a Product Support Investigator in Dundee, where you will play a crucial role in assessing and investigating product deficiencies. This position requires a degree in Biological Sciences and at least three years of experience in the life sciences or a regulated industry. You will log and assess user complaints, conduct investigations, and contribute to continuous improvement initiatives. If you're passionate about quality and compliance in the IVD field, this role offers a unique opportunity to make a significant impact within a dedicated team.

Qualifications

• 3+ years in life sciences or regulated industry.
• Practical knowledge of IVD product deficiencies.

Responsibilities

• Log and assess product deficiencies for reportability.
• Investigate causes of product deficiencies and report findings.

Skills

Complaint Logging

Root Cause Analysis (RCA)

Risk Assessment

ISO 13485:2016 Standards

Communication Skills

Education

Degree in Biological Sciences

Tools

Complaint Management Software (SFDC)

ERP Systems

Electronic Document Management Systems (EDMS)

MS Word

MS Excel

MS PowerPoint

CAPA Systems (Agile)

Job description

Job Title: Product Support Investigator

Location: Dundee

Pay rate: £13.85

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 logging, assessing the reportability of end user complaints, and conducting investigations at Abbott Dundee.

Main Responsibilities

• Log, acknowledge, and assess all alleged product deficiencies received from end users for adverse event reportability, adhering to site procedures.
• Investigate, establish, and report causes of product deficiencies.
• Log and acknowledge Supplier Corrective Actions (SCARS), taking full accountability for personal workload and ensuring work is completed to a high standard in accordance with site policies, procedures, and regulations.
• Contribute proactively to continuous improvement initiatives and perform general housekeeping duties.
• Engage in self-motivated professional development and participate in site training initiatives.
• Develop and maintain excellent relations within the department and wider Operations group.
• Propose ideas to improve communication and productivity.
• Understand and enact policies as set out in the Client's Employee Handbook appropriately.

Qualifications

Education

Degree in Biological Sciences with at least 3 years of practical experience in an IVD manufacturing environment.

Experience/Background

• Minimum of 3 years' experience in the life sciences or a similarly regulated industry, preferably in In-vitro Diagnostics.
• Practical knowledge of complaint logging and investigation of IVD product deficiencies according to ISO 13485:2016 standards.
• Experience with complaint management software; SFDC preferred.
• Ability to utilize Root Cause Analysis (RCA) tools, including A3/DMAIC.
• Experience in conducting Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA).
• Experience with ERP systems and Electronic Document Management Systems (EDMS).
• Experience with CAPA systems, preferably Agile.
• Proficiency in MS Word, Excel, and PowerPoint.
• Ability to run IVD tests such as Immunoassay and Clinical Chemistry.

Randstad Business Support is acting as an Employment Business in relation to this vacancy.