Quality Engineer Product Complaints & Investigations

Purpose

This role is responsible for a quality engineer with product complaint investigation according to established company procedures and worldwide regulations and standards.

Duties

• Review documents related to incoming complaints, including formal reports, emails, and other communications.
• Make and document sound regulatory reporting decisions and justifications for global reporting requirements.
• Perform technical root cause analysis which may include assessment of design, device performance, and usability.
• Perform device functional tests.
• Apply statistical methods to conduct technical investigations and data analyses.
• Utilize standard analytical practices to evaluate field data, interpret log files, and identify discrepancies in results.
• Updates Complaint investigation summary with administrative information including complaint number, PC / AE report information, Device information etc.

Knowledge, Skills, and Abilities :