Product Support Investigator

1 week ago

Dundee, Dundee City, United Kingdom Randstad Delivery (GBS) Full time
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:

  • 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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