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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