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Product Support Investigator

Dundee

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:

The Product Support Investigator is responsible for logging, assessing the reportability of end-user complaints, and conducting investigations in accordance with site procedures and regulations.

Main Responsibilities:

Log, acknowledge, and assess alleged product deficiencies from end users for adverse event reportability within specified timelines.

Conduct thorough investigations to identify and report the cause of reported issues.

Manage Supplier Corrective Actions (SCARS) received and ensure timely resolution.

Contribute to continuous improvement initiatives and general housekeeping duties to enhance operational efficiency.

Engage in ongoing professional development and site training initiatives.

Foster excellent relations within the department team and broader Operations group to ensure effective collaboration.

Propose ideas and initiatives to enhance communication and productivity within the team.

Adhere to relevant policies and procedures outlined for the role.

Qualifications: Education:

Bachelor's degree in Biological Sciences or related field.

Experience/Background:

Minimum 3 years of practical experience in an IVD (In Vitro Diagnostics) manufacturing environment.

3 years of experience within life sciences or similarly regulated industry, with exposure to In-Vitro Diagnostics preferred.

Proficient in complaint logging and investigation of IVD product deficiencies per ISO 13485:2016 standards.

Experience with complaint management software, with preference for SFDC.

Proficient in Root Cause Analysis (RCA) tools, including A3/DMAIC methodologies.

Ability to contribute to Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA).

Familiarity with Enterprise Resource Planning (ERP) systems and Electronic Document Management Systems (EDMS).

Experience with Corrective and Preventive Action (CAPA) systems, with Agile experience preferred.

Strong proficiency in MS Word, Excel, and PowerPoint.

Hands-on experience running IVD tests such as Immunoassay and Clinical Chemistry.

Note: Preferred qualifications are indicated where applicable.

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

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